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 23 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	Proficient Rx LP	1b9b6db9-1bac-4252-a03c-18dc0271f05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861004 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	88af3365-1145-45a1-ab0f-1c794f0c13db	2023-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861010 unii: 786Z46389E
Metformin HCl	METFORMIN HCL	Bryant Ranch Prepack	4bdd2faa-2125-4139-b958-196393e31b7e	2023-05-24	Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861007 unii: 786Z46389E
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1ebaab3a-3d62-4c36-853f-c8784993eafb	2023-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	86627ff4-da1c-429d-991b-88e97f6967d6	2023-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	8ce6b615-2abd-4a5b-997b-11aa1aec142d	2023-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861004 unii: 786Z46389E
Metformin HCl	METFORMIN HCL	A-S Medication Solutions	4e345b8c-57ab-4f09-9cbe-1d255e9354ba	2023-03-21	Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861007 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a57e2890-d83b-488c-b221-2e8f8a78ed16	2023-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	76879512-3ab4-4acf-92e6-bba0fb75dd0e	2023-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a59327bd-a3ba-417b-9e91-4cd3a941e640	2023-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	a79d2674-071f-4641-9b11-406e02c5530a	2023-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861004 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	93b0878d-b039-4479-8315-6dabf7e70611	2023-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride Extended-Release 500mg	METFORMIN HYDROCHLORIDE	Calvin Scott & Co., Inc.	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	2023-02-07	Warnings	Exact identifier unii: 786Z46389E
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Macleods Pharmaceuticals Limited	623b3bc6-1b07-4a04-bc7a-7fc695adf063	2023-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	34aa1761-d16f-4bfc-b7fa-bf1b0387e8a3	2022-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861004 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d0bee456-c8cd-46a1-acb3-5313a8cddd30	2022-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861004 unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	474e2900-43bf-4ebe-9d29-4a7adb8a9429	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	6b8824c0-ece0-4b15-ba71-e893d6d2bfdf	2022-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E
Metformin HCl	METFORMIN HCL	Proficient Rx LP	53361a39-cb69-483b-a4be-3a4753bf1ba6	2022-06-01	Warnings, Adverse reactions	Exact identifier application number: ANDA090564 rxcui: 861004 unii: 786Z46389E
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Solco Healthcare US, LLC.	1016cad7-2198-483c-893b-e25fd397a226	2022-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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