63629-1119 NDC - FUROSEMIDE (FUROSEMIDE)

Drug Information

Product NDC: 63629-1119
Proprietary Name: Furosemide
Non Proprietary Name: furosemide
Active Ingredient(s): 80 mg/1 FUROSEMIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Increased Diuresis at Loop of Henle [PE]; Loop Diuretic [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Bryant Ranch Prepack
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA076796
Marketing Category:	ANDA
Start Marketing Date:	7/30/2020

Package Information

No.	Package Code	Package Description	Billing Unit
1	63629-1119-1	100 TABLET in 1 BOTTLE, PLASTIC (63629-1119-1)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63629-1119	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	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.
PROPRIETARY NAME	Furosemide	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.
NON PROPRIETARY NAME	furosemide	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the dosage form Code submitted by the firm.
START MARKETING DATE	7/30/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	This is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBER	ANDA076796	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Bryant Ranch Prepack	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
SUBSTANCE NAME	FUROSEMIDE	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.
ACTIVE NUMERATOR STRENGTH	80	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.
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]

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This page was last updated on: 11/21/2025

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