NDC Compounded Drug 63037-136-25 Ketamine Hydrochloride

Injection Intramuscular; Intravenous

Compounded Product Information
NDC Crossover Products Matching Ketamine Hcl
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	63037-136
NDC Package Code	63037-136-25
11-Digit NDC Billing Format NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.	63037013625
Package Description	5 mL in 1 SYRINGE, PLASTIC
Product Type What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.	Human Compounded Drug
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Ketamine Hcl
Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.	Ketamine Hcl
Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.	Ketamine Hydrochloride
Dosage Form	Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Route Name	Intramuscular; Intravenous -
Marketing Category	OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code	63037
Labeler Name What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Hikma Injectables Usa Inc.
Substance Name	Ketamine Hydrochloride
Active Ingredients Information	50 mg/5 mL
DEA Schedule What is the Drug Enforcement Administration (DEA) CIII Schedule? The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.	Schedule III (CIII) Substances
Reporting Period	2022-2

NDC Crossover Products Matching Ketamine Hydrochloride

NDC crossover of Ketamine Hcl with NDC 63037-136 a human compounded drug with other similar products matching the same substance name (Ketamine Hydrochloride) and the same administration route (intramuscular; intravenous) or dosage form (injection).

NDC	Proprietary Name	Non-Proprietary Name	Package Desc	Dosage Form	Route Name	Company Name
63037-137-25	Ketamine Hcl	Ketamine Hcl	1 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
63037-137-25	Ketamine Hcl	Ketamine Hcl	1 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
63037-137-25	Ketamine Hcl	Ketamine Hcl	1 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
63037-137-25	Ketamine Hcl	Ketamine Hcl	1 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
65302-529-05	Ketamine Hydrochloride	Ketamine Hydrochloride	5 mL in 1 SYRINGE	Injection	Intramuscular; Intravenous	The Ritedose Corporation
70092-119-44	Ketamine 10 Mg/ml In 5ml Ns Syr	Ketamine 10 Mg/ml In 5ml Ns Syr	5 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-119-44	Ketamine 10 Mg/ml In 5ml Ns Syr	Ketamine 10 Mg/ml In 5ml Ns Syr	5 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-119-44	Ketamine 10 Mg/ml In 5ml Ns Syr	Ketamine 10 Mg/ml In 5ml Ns Syr	5 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-119-44	Ketamine 10 Mg/ml In 5ml Ns Syr	Ketamine 10 Mg/ml In 5ml Ns Syr	5 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-120-43	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	1 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-120-43	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	1 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-120-43	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	1 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-120-43	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	Ketamine 50 Mg/ml 1 Ml- 3 Ml Syr	1 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-563-43	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-563-43	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-563-43	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-563-43	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	Ketamine 10 Mg/ml In 2 Ml Ns- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
71506-050-56	Ketamine Hydrochloride	Ketamine Hydrochloride	100 mL in 1 BAG	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
71506-050-56	Ketamine Hydrochloride	Ketamine Hydrochloride	100 mL in 1 BAG	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
71506-050-56	Ketamine Hydrochloride	Ketamine Hydrochloride	100 mL in 1 BAG	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
71506-050-56	Ketamine Hydrochloride	Ketamine Hydrochloride	100 mL in 1 BAG	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
71506-074-05	Ketamine Hydrochloride	Ketamine Hydrochloride	5 mL in 1 SYRINGE	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
71506-074-05	Ketamine Hydrochloride	Ketamine Hydrochloride	5 mL in 1 SYRINGE	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
71506-074-05	Ketamine Hydrochloride	Ketamine Hydrochloride	5 mL in 1 SYRINGE	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
71506-074-05	Ketamine Hydrochloride	Ketamine Hydrochloride	5 mL in 1 SYRINGE	Injection	Intravenous	Fresenius Kabi Compounding Llc Dba Fagron Sterile Services
72627-4000-2	Ketamine	Ketamine	10 mL in 1 VIAL, SINGLE-DOSE	Injection	Intramuscular; Intravenous	Empower Pharmacy
72627-4001-2	Ketamine	Ketamine	10 mL in 1 VIAL, MULTI-DOSE	Injection	Intramuscular; Intravenous	Empower Pharmacy
72627-4001-2	Ketamine	Ketamine	10 mL in 1 VIAL, MULTI-DOSE	Injection	Intramuscular; Intravenous	Empower Pharmacy
73177-101-02	Ketamine Hydrochloride	Ketamine Hydrochloride	5 mL in 1 SYRINGE, PLASTIC	Injection	Intravenous	Staq Pharma Inc
73177-101-02	Ketamine Hydrochloride	Ketamine Hydrochloride	5 mL in 1 SYRINGE, PLASTIC	Injection	Intravenous	Staq Pharma Inc

Frequently Asked Questions

What is the NDC number assigned to Ketamine Hydrochloride?

Ketamine Hydrochloride was assigned by its manufacturer with NDC product code 63037-136. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Ketamine Hydrochloride?

The NDC package code 63037-136-25 was assigned to a 5 mL in 1 SYRINGE, PLASTIC of ketamine hydrochloride administered intramuscular; intravenous via injection.

Who manufactures this product?

Ketamine Hydrochloride is manufactured by an outsourced facility and labeled by Hikma Injectables Usa Inc.. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 30 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Hikma Injectables USA Inc., The Ritedose Corporation, QuVa Pharma, Inc., Fresenius Kabi Compounding LLC DBA Fagron Sterile Services, Empower Pharmacy and STAQ Pharma Inc with NDC product codes 63037-137-25, 63037-137-25, 63037-137-25, 63037-137-25, 65302-529-05, 70092-119-44, 70092-119-44, 70092-119-44, 70092-119-44, 70092-120-43, 70092-120-43, 70092-120-43, 70092-120-43, 70092-563-43, 70092-563-43, 70092-563-43, 70092-563-43, 71506-050-56, 71506-050-56, 71506-050-56, 71506-050-56, 71506-074-05, 71506-074-05, 71506-074-05, 71506-074-05, 72627-4000-2, 72627-4001-2, 72627-4001-2, 73177-101-02 and 73177-101-02.

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