DailyMed - METFORMIN HYDROCHLORIDE tablet, film coated

NDC Code(s): 65841-028-01, 65841-028-05, 65841-028-10, 65841-028-16, view more
65841-028-30, 65841-028-77, 65841-029-01, 65841-029-05, 65841-029-10, 65841-029-16, 65841-029-30, 65841-029-77, 65841-030-01, 65841-030-05, 65841-030-10, 65841-030-16, 65841-030-30, 65841-030-77, 65841-809-01, 65841-809-05, 65841-809-10, 65841-809-16, 65841-809-30, 65841-809-77, 65841-810-01, 65841-810-05, 65841-810-10, 65841-810-16, 65841-810-30, 65841-810-77, 65841-811-01, 65841-811-05, 65841-811-10, 65841-811-16, 65841-811-30, 65841-811-77
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 31, 2022

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SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-028-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 500 mg

Rx only

100 tablets

NDC 65841-809-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 500 mg

Rx only

100 tablets

NDC 65841-029-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 850 mg

Rx only

100 tablets

NDC 65841-810-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 850 mg

Rx only

100 tablets

NDC 65841-030-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 1000 mg

Rx only

100 tablets

NDC 65841-811-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 1000 mg

Rx only

100 tablets

INGREDIENTS AND APPEARANCE

METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-028
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	500 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	13mm
Flavor		Imprint Code	70;Z
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-028-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
2	NDC:65841-028-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
3	NDC:65841-028-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
4	NDC:65841-028-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
5	NDC:65841-028-77	100 in 1 CARTON	09/28/2005
5	NDC:65841-028-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077064	09/28/2005

METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-029
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	850 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	19mm
Flavor		Imprint Code	69;Z
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-029-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
2	NDC:65841-029-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
3	NDC:65841-029-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
4	NDC:65841-029-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
5	NDC:65841-029-77	100 in 1 CARTON	09/28/2005
5	NDC:65841-029-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077064	09/28/2005

METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-030
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	1000 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	OVAL (OVAL)	Size	19mm
Flavor		Imprint Code	Z;71
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-030-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
2	NDC:65841-030-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
3	NDC:65841-030-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
4	NDC:65841-030-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
5	NDC:65841-030-77	100 in 1 CARTON	09/28/2005
5	NDC:65841-030-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077064	09/28/2005

METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-809
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	500 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	13mm
Flavor		Imprint Code	70;Z
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-809-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
2	NDC:65841-809-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
3	NDC:65841-809-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
4	NDC:65841-809-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
5	NDC:65841-809-77	100 in 1 CARTON	12/09/2014
5	NDC:65841-809-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203686	12/09/2014

METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-810
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	850 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	19mm
Flavor		Imprint Code	69;Z
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-810-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
2	NDC:65841-810-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
3	NDC:65841-810-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
4	NDC:65841-810-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
5	NDC:65841-810-77	100 in 1 CARTON	12/09/2014
5	NDC:65841-810-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203686	12/09/2014

METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-811
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	1000 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	OVAL (OVAL)	Size	19mm
Flavor		Imprint Code	Z;71
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-811-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
2	NDC:65841-811-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
3	NDC:65841-811-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
4	NDC:65841-811-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2014
5	NDC:65841-811-77	100 in 1 CARTON	12/09/2014
5	NDC:65841-811-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203686	12/09/2014

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811)

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Published Date (What is this?)	Version	Files
Nov 2, 2022	11 (current)	download
Nov 23, 2021	10	download
Sep 8, 2020	9	download
Dec 13, 2019	8	download
Jul 10, 2018	7	download
Mar 26, 2018	6	download
Nov 24, 2017	5	download
Dec 9, 2014	4	download
Nov 14, 2011	3	download
May 18, 2011	1	download

	RxCUI	RxNorm NAME	RxTTY
1	860975	metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN
2	860975	24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD
3	860975	metformin HCl 500 MG 24 HR Extended Release Oral Tablet	SY
4	861004	metFORMIN HCl 1000 MG Oral Tablet	PSN
5	861004	metformin hydrochloride 1000 MG Oral Tablet	SCD
6	861004	metformin HCl 1 GM Oral Tablet	SY
7	861007	metFORMIN HCl 500 MG Oral Tablet	PSN
8	861007	metformin hydrochloride 500 MG Oral Tablet	SCD
9	861010	metFORMIN HCl 850 MG Oral Tablet	PSN
10	861010	metformin hydrochloride 850 MG Oral Tablet	SCD

Label: METFORMIN HYDROCHLORIDE tablet, film coated

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	NDC
1	65841-028-01
2	65841-028-05
3	65841-028-10
4	65841-028-16
5	65841-028-30
6	65841-028-77
7	65841-029-01
8	65841-029-05
9	65841-029-10
10	65841-029-16
11	65841-029-30
12	65841-029-77
13	65841-030-01
14	65841-030-05
15	65841-030-10
16	65841-030-16
17	65841-030-30
18	65841-030-77
19	65841-809-01
20	65841-809-05
21	65841-809-10
22	65841-809-16
23	65841-809-30
24	65841-809-77
25	65841-810-01
26	65841-810-05
27	65841-810-10
28	65841-810-16
29	65841-810-30
30	65841-810-77
31	65841-811-01
32	65841-811-05
33	65841-811-10
34	65841-811-16
35	65841-811-30
36	65841-811-77

Label: METFORMIN HYDROCHLORIDE tablet, film coated

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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Safety

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More Info on this Drug

METFORMIN HYDROCHLORIDE tablet, film coated

Number of versions: 10

METFORMIN HYDROCHLORIDE tablet, film coated

METFORMIN HYDROCHLORIDE tablet, film coated

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METFORMIN HYDROCHLORIDE tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.