NDC 0591-2775 - Metformin Hydrochloride

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: 0591-2775
Package NDCs from labels: 0591-2775-60, 0591-2775-01, 0591-2775-25
Manufacturer: Watson Laboratories, Inc.
Effective date: 2006-04-05
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 Rx only	Watson Laboratories, Inc.	2006-04-05	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0591-2775-01	Metformin Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
0591-2775-25	Metformin Hydrochloride	250 in 1 BOTTLE	TABLET, FILM COATED	250	1
0591-2775-60	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2775	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1	3 package rows	20060828_A757F9F8-A925-4E47-9B83-131CCCF8E470.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Metformin Hydrochloride	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
Metformin	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
hypromellose	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
microcrystalline cellulose	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
povidone	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
red iron oxide	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
tricetin	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
vanillin	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1
yellow iron oxide	INACTIVE INGREDIENT		METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]	1

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 9 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	ACI Healthcare USA, Inc.	e18b60f9-721e-4db6-9f61-d3437e18faf2	2020-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Epic Pharma, LLC	8c1848f9-c113-4552-b6ef-715e72630ad9	2019-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	5c2581e3-2b30-4da5-8bed-228173ca20d2	2019-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Metcure Pharmaceuticals, Inc.	5df6adc9-79fd-66ef-e053-2991aa0a75ce	2018-01-22	Boxed warning, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004
Metformin HCl	METFORMIN HCL	Ascend Laboratories, LLC	2d98aea3-35ba-447a-b88f-a5a20b612b2f	2017-02-07	Warnings, Adverse reactions	Exact identifier rxcui: 861007 rxcui: 861010 rxcui: 861004
A757F9F8-A925-4E47-9B83-131CCCF8E470			A757F9F8-A925-4E47-9B83-131CCCF8E470	2006-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: A757F9F8-A925-4E47-9B83-131CCCF8E470 spl set id: A757F9F8-A925-4E47-9B83-131CCCF8E470

Reported adverse events (FAERS/openFDA)#

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