METFORMIN HYDROCHLORIDE

Product NDC: 68788-8866
11-digit product format: 687888866
Labeler code: 68788
Product ID: 68788-8866_103080cb-6381-44f6-8a31-1fc81e7c890f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METFORMIN HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA217631
Marketing category: ANDA
Marketing start: 2025-04-23
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data

Finished product: Yes
Brand name base: METFORMIN HYDROCHLORIDE
Listing expiration: 2026-12-31

Related Records

DailyMed label linked from SPL set ID

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

Harmonized Identifiers

Field	Values
Unii	786Z46389E
Rxcui	860975

Related Records

Related UNII Ingredients

UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-8866-1	68788886601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-1)	2025-04-23	No	No	Historical
68788-8866-3	68788886603	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-3)	2025-04-23	No	No	Historical
68788-8866-6	68788886606	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-6)	2025-04-23	No	No	Historical
68788-8866-8	68788886608	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-8)	2025-04-23	No	No	Historical
68788-8866-9	68788886609	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-9)	2025-04-23	No	No	Historical

Related DailyMed Labels

Title	Manufacturer	Effective date	Type	Version
METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2025-04-23	HUMAN PRESCRIPTION DRUG LABEL	1