METACRESOL
UNII GGO4Y809LO

Substance Identification & Data

This profile provides standardized clinical and technical data for Metacresol, uniquely identified by the FDA Unique Ingredient Identifier (UNII) GGO4Y809LO.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 108-39-4 and the RxNorm Concept ID (RxCUI) 1367170. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
GGO4Y809LO
CAS Registry Number
108-39-4
RxNorm Concept ID
1367170

Detailed Substance Profile

Preferred Name
METACRESOL
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
GGO4Y809LO
The specific atomic composition represented as a molecular structure string.
InChIKey
C7H8O
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
RLSSMJSEOOYNOY-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C80603
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
342
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
c1c(O)cccc1C

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Metacresol. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

M-CRESOL

Common Names & Synonyms

AMYLMETACRESOL IMPURITY B [EP IMPURITY]
M-CRESOL [WHO-DD]
M-CRESYLIC ACID
METACRESOL [EP IMPURITY]
METACRESOL [EP MONOGRAPH]
METACRESOL [HSDB]
METACRESOL [II]
METACRESOL [USP IMPURITY]
METACRESOL [USP MONOGRAPH]
METACRESOL [USP-RS]
M-KRESOL

Systematic Nomenclature

1-HYDROXY-3-METHYLBENZENE
1-METHYL-3-HYDROXYBENZENE
3-CRESOL
3-HYDROXYTOLUENE
3-METHYLPHENOL
CRESOL, M-
METACRESOL
META-CRESOL
M-METHYLPHENOL
PHENOL, 3-METHYL-

Technical Codes

FEMA NO. 3530
NSC-8768

NDC Products Containing METACRESOL

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

Manufacturer Quick Index

Note: Due to the high number of listings (192), only Active Listings are currently displayed.
→ A-S Medication Solutions 31
→ Alembic Pharmaceuticals Inc. 4
→ Alvogen Inc. 1
→ Alvogen, Inc. 1
→ Amneal Pharmaceuticals LLC 2
→ Amphastar Pharmaceuticals, Inc. 1
→ Apotex Corp. 1
→ Biocon Biologics Inc. 5
→ BluePoint Laboratories 1
→ Civica, Inc. 2
→ Dr.Reddy's Laboratories Inc., 5
→ EMD Serono, Inc. 3
→ Eli Lilly and Company 29
→ Ferring Pharmaceuticals Inc. 1
→ Hospira, Inc. 1
→ Novo Nordisk 14
→ Novo Nordisk Pharma, Inc. 8
→ Pfizer Laboratories Div Pfizer Inc 2
→ REMEDYREPACK INC. 4
→ Sandoz Inc 5
→ Sanofi-Aventis U.S. LLC 10
→ Teva Parenteral Medicines, Inc. 4
→ Teva Pharmaceuticals USA, Inc. 1
→ United Therapeutics Corporation 5
→ sanofi-aventis U.S. LLC 4

A-S Medication Solutions

NDC Product
Human Otc Drug

Humulin R
NDC 50090-0353

Generic Name
Insulin Human
Dosage Form
Injection, Solution
Route
Parenteral
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Novolin 70/30
NDC 50090-0403

Generic Name
Human Insulin
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lantus
NDC 50090-0876

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Levemir
NDC 50090-1276

Generic Name
Insulin Detemir
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog
NDC 50090-1375

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lantus Solostar
NDC 50090-1398

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Kwikpen
NDC 50090-1663

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog
NDC 50090-1664

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Toujeo
NDC 50090-2193

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog Mix 70/30
NDC 50090-2272

Generic Name
Insulin Aspart
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Tresiba
NDC 50090-3491

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lantus Solostar
NDC 50090-4068

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Kwikpen
NDC 50090-4073

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog Mix 70/30
NDC 50090-4085

Generic Name
Insulin Aspart
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Toujeo Max
NDC 50090-4177

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog
NDC 50090-4488

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog
NDC 50090-4500

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Aspart
NDC 50090-4955

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Aspart
NDC 50090-4956

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Lispro
NDC 50090-5391

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Glargine Solostar
NDC 50090-6178

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Levemir
NDC 50090-6391

Generic Name
Insulin Detemir
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Levemir
NDC 50090-6414

Generic Name
Insulin Detemir
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Rezvoglar Kwikpen
NDC 50090-6439

Generic Name
Insulin Glargine-aglr
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Novolin N
NDC 50090-6565

Generic Name
Human Insulin
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Tresiba
NDC 50090-7077

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Tresiba
NDC 50090-7094

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Degludec
NDC 50090-7175

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Degludec
NDC 50090-7176

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev
NDC 50090-7433

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing

Alembic Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Treprostinil
NDC 62332-514

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 62332-515

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 62332-516

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 62332-517

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing

Alvogen Inc.

NDC Product
Human Prescription Drug

Bonsity
NDC 47781-852

Generic Name
Teriparatide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
NDA
Active Listing

Alvogen, Inc.

NDC Product
Human Prescription Drug

Teriparatide
NDC 47781-652

Generic Name
Teriparatide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
NDA
Active Listing

Amneal Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Exenatide
NDC 70121-1685

Generic Name
Exenatide
Dosage Form
Injection
Route
Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Exenatide
NDC 70121-1686

Generic Name
Exenatide
Dosage Form
Injection
Route
Subcutaneous
Marketing
ANDA
Active Listing

Amphastar Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Teriparatide
NDC 0548-2311

Generic Name
Teriparatide
Dosage Form
Injection
Route
Subcutaneous
Marketing
ANDA
Active Listing

Apotex Corp.

NDC Product
Human Prescription Drug

Teriparatide
NDC 60505-6188

Generic Name
Teriparatide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing

Biocon Biologics Inc.

NDC Product
Human Prescription Drug

Insulin Diluting Medium For Kirsty
NDC 83257-006

Generic Name
Water
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Kirsty
NDC 83257-007

Generic Name
Insulin Aspart-xjhz
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Kirsty
NDC 83257-008

Generic Name
Insulin Aspart-xjhz
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Glargine
NDC 83257-014

Generic Name
Insulin Glargine-yfgn
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Glargine
NDC 83257-015

Generic Name
Insulin Glargine-yfgn
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

BluePoint Laboratories

NDC Product
Human Prescription Drug

Teriparatide
NDC 68001-693

Generic Name
Teriparatide
Dosage Form
Injection
Route
Subcutaneous
Marketing
ANDA
Active Listing

Civica, Inc.

NDC Product
Human Prescription Drug

Insulin Glargine
NDC 72572-422

Generic Name
Insulin Glargine-yfgn
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Glargine
NDC 72572-424

Generic Name
Insulin Glargine-yfgn
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Dr.Reddy's Laboratories Inc.,

NDC Product
Human Prescription Drug

Sterile Diluent For Treprostinil
NDC 43598-126

Generic Name
Water
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 43598-646

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 43598-647

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 43598-648

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 43598-649

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing

EMD Serono, Inc.

NDC Product
Human Prescription Drug

Gonal-f Rff Redi-ject
NDC 44087-1115

Generic Name
Follitropin
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Gonal-f Rff Redi-ject
NDC 44087-1116

Generic Name
Follitropin
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Gonal-f Rff Redi-ject
NDC 44087-1117

Generic Name
Follitropin
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Eli Lilly and Company

NDC Product
Human Prescription Drug

Humalog
NDC 0002-7510

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Mix75/25
NDC 0002-7511

Generic Name
Insulin Lispro
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog
NDC 0002-7516

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Kwikpen
NDC 0002-7712

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Junior Kwikpen
NDC 0002-7714

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Basaglar Kwikpen
NDC 0002-7715

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev
NDC 0002-7726

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev
NDC 0002-7728

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Lispro
NDC 0002-7737

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Lispro Junior Kwikpen
NDC 0002-7752

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humatrope
NDC 0002-8147

Generic Name
Somatropin
Dosage Form
Kit
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humatrope
NDC 0002-8148

Generic Name
Somatropin
Dosage Form
Kit
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humatrope
NDC 0002-8149

Generic Name
Somatropin
Dosage Form
Kit
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev Kwikpen
NDC 0002-8207

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Humulin R
NDC 0002-8215

Generic Name
Insulin Human
Dosage Form
Injection, Solution
Route
Parenteral
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Lispro Kwikpen
NDC 0002-8222

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev Kwikpen
NDC 0002-8228

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Humulin N
NDC 0002-8315

Generic Name
Insulin Human
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lyumjev Junior Kwikpen
NDC 0002-8351

Generic Name
Insulin Lispro-aabc
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humulin R U-500
NDC 0002-8501

Generic Name
Insulin Human
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Humulin 70/30
NDC 0002-8715

Generic Name
Insulin Human
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Mix75/25 Kwikpen
NDC 0002-8797

Generic Name
Insulin Lispro
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Mix50/50 Kwikpen
NDC 0002-8798

Generic Name
Insulin Lispro
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humalog Kwikpen
NDC 0002-8799

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Humulin 70/30 Kwikpen
NDC 0002-8803

Generic Name
Insulin Human
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Humulin N
NDC 0002-8805

Generic Name
Insulin Human
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Humulin R U-500 Kwikpen
NDC 0002-8824

Generic Name
Insulin Human
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Rezvoglar Kwikpen
NDC 0002-8980

Generic Name
Insulin Glargine-aglr
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Ferring Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Zomacton
NDC 55566-1901

Generic Name
Somatropin
Dosage Form
Kit
Route
Subcutaneous
Marketing
BLA
Active Listing

Hospira, Inc.

NDC Product
Human Prescription Drug

Demerol
NDC 0409-1181

Generic Name
Meperidine Hydrochloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous; Subcutaneous
Marketing
NDA
Active Listing

Novo Nordisk

NDC Product
Human Otc Drug

Novolin R
NDC 0169-1833

Generic Name
Human Insulin
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Novolin N
NDC 0169-1834

Generic Name
Human Insulin
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Otc Drug

Novolin 70/30
NDC 0169-1837

Generic Name
Human Insulin
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Tresiba
NDC 0169-2550

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Tresiba
NDC 0169-2660

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Awiqli
NDC 0169-3105

Generic Name
Insulin Icodec-abae
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Awiqli
NDC 0169-3121

Generic Name
Insulin Icodec-abae
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Awiqli
NDC 0169-3170

Generic Name
Insulin Icodec-abae
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog
NDC 0169-3303

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog Mix 70/30
NDC 0169-3685

Generic Name
Insulin Aspart
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog Mix 70/30
NDC 0169-3696

Generic Name
Insulin Aspart
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog
NDC 0169-6338

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog
NDC 0169-6339

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Novolog
NDC 0169-7501

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing

Novo Nordisk Pharma, Inc.

NDC Product
Human Prescription Drug

Insulin Aspart
NDC 73070-100

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Aspart
NDC 73070-102

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Aspart
NDC 73070-103

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Degludec
NDC 73070-400

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Degludec
NDC 73070-403

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Degludec
NDC 73070-503

Generic Name
Insulin Degludec
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Ngenla
NDC 0069-0505

Generic Name
Somatrogon-ghla
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Ngenla
NDC 0069-0520

Generic Name
Somatrogon-ghla
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

REMEDYREPACK INC.

NDC Product
Human Prescription Drug

Novolog Mix 70/30
NDC 70518-2119

Generic Name
Insulin Aspart
Dosage Form
Injection, Suspension
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Aspart
NDC 70518-3865

Generic Name
Insulin Aspart
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Admelog
NDC 70518-4275

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Sandoz Inc

NDC Product
Human Prescription Drug

Treprostinil
NDC 0781-3420

Generic Name
Treprostinil
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 0781-3425

Generic Name
Treprostinil
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 0781-3427

Generic Name
Treprostinil
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 0781-3430

Generic Name
Treprostinil
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diluent
NDC 0781-6021

Generic Name
Water Solution
Dosage Form
Injection
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Soliqua 100/33
NDC 0024-5761

Generic Name
Insulin Glargine And Lixisenatide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Toujeo
NDC 0024-5869

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Toujeo Max
NDC 0024-5871

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Admelog
NDC 0024-5924

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Admelog
NDC 0024-5925

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Admelog
NDC 0024-5926

Generic Name
Insulin Lispro
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Merilog
NDC 0024-5927

Generic Name
Insulin Aspart-szjj
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Merilog
NDC 0024-5928

Generic Name
Insulin Aspart-szjj
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Glargine U-300 Max
NDC 0955-2900

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Insulin Glargine U-300
NDC 0955-3900

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

Teva Parenteral Medicines, Inc.

NDC Product
Human Prescription Drug

Treprostinil
NDC 0703-0666

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 0703-0676

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 0703-0686

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Treprostinil
NDC 0703-0696

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
ANDA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Teriparatide
NDC 0093-1106

Generic Name
Teriparatide
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
ANDA
Active Listing

United Therapeutics Corporation

NDC Product
Human Prescription Drug

Remodulin
NDC 66302-101

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Remodulin
NDC 66302-102

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Remodulin
NDC 66302-105

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Remodulin
NDC 66302-110

Generic Name
Treprostinil
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sterile Diluent For Remodulin
NDC 66302-150

Generic Name
Water
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing

sanofi-aventis U.S. LLC

NDC Product
Human Prescription Drug

Lantus Solostar
NDC 0088-2219

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Lantus
NDC 0088-2220

Generic Name
Insulin Glargine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Apidra
NDC 0088-2500

Generic Name
Insulin Glulisine
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Apidra Solostar
NDC 0088-2502

Generic Name
Insulin Glulisine
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing

External Clinical & Regulatory Resources

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NLM
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