NDC Compounded Drug 63037-101-05 Fentanyl Citrate

Injection Intravenous

Compounded Product Information
NDC Crossover Products Matching Fentanyl Citrate In 0.9% Sodium Chloride
Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code	63037-101
NDC Package Code	63037-101-05
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.	63037010105
Package Description	250 mL in 1 BAG
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.	Fentanyl Citrate In 0.9% Sodium Chloride
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.	Fentanyl Citrate In 0.9% Sodium Chloride Injection
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.	Fentanyl Citrate
Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.	This medication is used to help relieve sudden (breakthrough) pain in people who are already taking opioid medication around-the-clock for cancer pain. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).
Dosage Form	Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Route Name	Intravenous - Administration within or into a vein or veins.
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	Fentanyl Citrate
Active Ingredients Information	2500 ug/250 mL
DEA Schedule What is the Drug Enforcement Administration (DEA) CII Schedule? The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs.	Schedule II (CII) Substances
Reporting Period	2023-1

NDC Crossover Products Matching Fentanyl Citrate

NDC crossover of Fentanyl Citrate In 0.9% Sodium Chloride with NDC 63037-101 a human compounded drug with other similar products matching the same substance name (Fentanyl Citrate) and the same administration route (intravenous) or dosage form (injection).

NDC	Proprietary Name	Non-Proprietary Name	Package Desc	Dosage Form	Route Name	Company Name
51754-9150-1	Fentanyl Citrate	Fentanyl Citrate Injection 2500 Mcg/50 Ml	50 mL in 1 VIAL, GLASS	Injection	Intravenous	Exela Pharma Sciences, Llc.
51754-9160-1	Fentanyl Citrate	Fentanyl Citrate Injection 5000 Mcg/100 Ml	100 mL in 1 VIAL, GLASS	Injection	Intravenous	Exela Pharma Sciences, Llc.
60652-6030-1	Fentanyl Citrate Drip	Fentanyl Citrate Drip	50 mL in 1 BAG	Injection	Intravenous	Ssm Hlth St Clare Hosp-fnton
60652-6030-1	Fentanyl Citrate Drip	Fentanyl Citrate Drip	50 mL in 1 BAG	Injection	Intravenous	Ssm Hlth St Clare Hosp-fnton
60652-6030-1	Fentanyl Citrate Drip	Fentanyl Citrate Drip	50 mL in 1 BAG	Injection	Intravenous	Ssm Health Care St. Louis D/b/a Ssm Health St. Clare-fenton
60652-6030-1	Fentanyl Citrate Drip	Fentanyl Citrate Drip	50 mL in 1 BAG	Injection	Intravenous	Ssm Hlth St Clare Hosp-fnton
60652-9010-1	Fentanyl Citrate	Fentanyl Citrate	1 mL in 1 VIAL, GLASS	Injection	Intravenous	Ssm Hlth St Clare Hosp-fnton
63037-100-05	Fentanyl Citrate In 0.9 % Sodium Chloride	Fentanyl Citrate In 0.9% Sodium Chloride Injection	100 mL in 1 BAG	Injection	Intravenous	Hikma Injectables Usa Inc.
63037-100-05	Fentanyl Citrate In 0.9 % Sodium Chloride	Fentanyl Citrate In 0.9% Sodium Chloride Injection	100 mL in 1 BAG	Injection	Intravenous	Hikma Injectables Usa Inc.
63037-100-05	Fentanyl Citrate In 0.9 % Sodium Chloride	Fentanyl Citrate In 0.9% Sodium Chloride Injection	100 mL in 1 BAG	Injection	Intravenous	Hikma Injectables Usa Inc.
63037-100-05	Fentanyl Citrate In 0.9 % Sodium Chloride	Fentanyl Citrate In 0.9% Sodium Chloride Injection	100 mL in 1 BAG	Injection	Intravenous	Hikma Injectables Usa Inc.
63037-190-25	Fentanyl Citrate	Fentanyl Citrate	2 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
63037-190-25	Fentanyl Citrate	Fentanyl Citrate	2 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
63037-191-25	Fentanyl Citrate	Fentanyl Citrate	5 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
63037-191-25	Fentanyl Citrate	Fentanyl Citrate	5 mL in 1 SYRINGE, PLASTIC	Injection	Intramuscular; Intravenous	Hikma Injectables Usa Inc.
70092-092-36	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	100 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-092-36	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	100 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-092-36	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	100 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-092-36	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 100 Ml Ns Ivb	100 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-093-37	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	250 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-093-37	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	250 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-093-37	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	250 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-093-37	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	Fentanyl Pf 10 Mcg/ml In 250 Ml Ns Ivb	250 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-094-36	Fentanyl Pf 20 Mcg/ml In 100 Ml Ns Ivb	Fentanyl Pf 20 Mcg/ml In 100 Ml Ns Ivb	100 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-094-36	Fentanyl Pf 20 Mcg/ml In 100 Ml Ns Ivb	Fentanyl Pf 20 Mcg/ml In 100 Ml Ns Ivb	100 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-094-36	Fentanyl Pf 20 Mcg/ml In 100 Ml Ns Ivb	Fentanyl Pf 20 Mcg/ml In 100 Ml Ns Ivb	100 mL in 1 BAG	Injection	Intravenous	Quva Pharma, Inc.
70092-097-43	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-097-43	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-097-43	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.
70092-097-43	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr	2 mL in 1 SYRINGE	Injection	Intravenous	Quva Pharma, Inc.

Frequently Asked Questions

What is the NDC number assigned to Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr?

Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr was assigned by its manufacturer with NDC product code 63037-101. 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 Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr?

The NDC package code 63037-101-05 was assigned to a 250 mL in 1 BAG of fentanyl citrate administered intravenous via injection.

Who manufactures this product?

Fentanyl Pf 50 Mcg/ml 2ml- 3 Ml Syr 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 Exela Pharma Sciences, LLC., Ssm Hlth St Clare Hosp-Fnton, SSM Health Care St. Louis d/b/a SSM Health St. Clare-Fenton, Hikma Injectables USA Inc. and QuVa Pharma, Inc. with NDC product codes 51754-9150-1, 51754-9160-1, 60652-6030-1, 60652-6030-1, 60652-6030-1, 60652-6030-1, 60652-9010-1, 63037-100-05, 63037-100-05, 63037-100-05, 63037-100-05, 63037-190-25, 63037-190-25, 63037-191-25, 63037-191-25, 70092-092-36, 70092-092-36, 70092-092-36, 70092-092-36, 70092-093-37, 70092-093-37, 70092-093-37, 70092-093-37, 70092-094-36, 70092-094-36, 70092-094-36, 70092-097-43, 70092-097-43, 70092-097-43 and 70092-097-43.

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