NDC 68071-3697-01 - Metformin HCl

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68071-3697
Requested NDC: 68071-3697-01
Package NDCs from labels: 68071-3697-1, 68071-3697-01
Manufacturer: NuCare Pharmaceuticals, Inc.
Effective date: 2024-10-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Metformin Hydrochloride Tablets USP	NuCare Pharmaceuticals, Inc.	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3697-1	Metformin HCl	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3697	METFORMIN HCL TABLET [NUCARE PHARMACEUTICALS, INC.]	1	Current NDC, 1 package rows	20241012_242256af-c587-060a-e063-6294a90a68cc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 25 · 482 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Metcure Pharmaceuticals, Inc.	5df6adc9-79fd-66ef-e053-2991aa0a75ce	2018-01-22	Boxed warning, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861007 rxcui: 861010 rxcui: 861004 unii: 786Z46389E
Metformin HCl	METFORMIN HCL	Ascend Laboratories, LLC	2d98aea3-35ba-447a-b88f-a5a20b612b2f	2017-02-07	Warnings, Adverse reactions	Exact identifier application number: ANDA090564 ndc (product): 67877-563 rxcui: 861007 rxcui: 861010 rxcui: 861004 spl id: 2d98aea3-35ba-447a-b88f-a5a20b612b2f spl set id: 2d98aea3-35ba-447a-b88f-a5a20b612b2f unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.