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 3 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	8936f66f-10fe-44ab-a26e-dd8b05dfa997	2026-08-10	Warnings	Exact identifier unii: B697894SGQ
Leader Lubricant Eye Drops 30ct	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CARDINAL HEALTH 110, LLC. DBA LEADER	8df69f2c-40c4-245c-e053-2a95a90a5406	2026-08-05	Warnings	Exact identifier unii: B697894SGQ
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	c1bfc7b5-c7e0-4353-b772-05d463c12886	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861010 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4d087f00-580b-4b9d-80d9-f97930153e72	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5d8d654a-9bb4-4c87-ab43-c21c4e874708	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861004 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	583f2a2e-a9d7-f266-e063-6294a90ad0ab	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861004 unii: 786Z46389E
Metformin HCl	METFORMIN HCL	PD-Rx Pharmaceuticals, Inc.	c8e50300-1838-4c51-8d9d-ebbaaf0f3991	2026-08-03	Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861007 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1d0b74de-ef4c-4dd2-8019-2ddb409c60b4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	59a4ccda-5487-4ac4-9373-0c0fc8b7c88b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861004 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f55a245b-a786-4a4a-b11c-c61d48294b01	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9171d369-d35a-40e4-a9ad-26484e66fc5e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	30658e19-8e6e-49aa-a007-e414224797c5	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861007 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Cardinal Health 107, LLC	46cb7e3f-c739-433d-9dbe-427c2d95bef1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861007 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Chartwell RX, LLC	4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004 unii: 786Z46389E
Metformin ER 500 mg	METFORMIN ER 500 MG	Granules India Ltd	b857eccf-b9ff-45ba-8241-f47f5caada2a	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	13235d8e-ac3a-45b4-9c5d-9a9012951dfe	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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