29300-389 NDC - METFORMIN HYDROCHLORIDE

Drug Information

Product NDC: 29300-389
Proprietary Name: Metformin Hydrochloride
Non Proprietary Name: Metformin Hydrochloride
Active Ingredient(s): 500 mg/1 METFORMIN HYDROCHLORIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET, EXTENDED RELEASE
Pharmacy Class(es): Biguanide [EPC]; Biguanides [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Unichem Pharmaceuticals (USA), Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA213359
Marketing Category:	ANDA
Start Marketing Date:	8/11/2021

Package Information

No.	Package Code	Package Description	Billing Unit
1	29300-389-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-01)	EA
2	29300-389-05	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-05)	EA
3	29300-389-10	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-10)
4	29300-389-19	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-19)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	29300-389	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	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.
PROPRIETARY NAME	Metformin Hydrochloride	Name of Company corresponding to the labeler code segment of the Product NDC.
NON PROPRIETARY NAME	Metformin Hydrochloride	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, EXTENDED RELEASE	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/11/2021	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	ANDA213359	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	Unichem Pharmaceuticals (USA), Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	METFORMIN HYDROCHLORIDE	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	500
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Biguanide [EPC], Biguanides [CS]

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This page was last updated on: 12/6/2025

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