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NDC 65841-0027-01 METFORMIN HYDROCHLORIDE 500 mg/1 Details

METFORMIN HYDROCHLORIDE 500 mg/1

METFORMIN HYDROCHLORIDE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is METFORMIN HYDROCHLORIDE.

MedlinePlus Drug Summary

Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by your liver. Metformin also increases your body's response to insulin, a natural substance that controls the amount of glucose in the blood. Metformin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Related Packages: 65841-0027-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Metformin

Product Information

NDC	65841-0027
Product ID	65841-027_98157d0e-cac3-45cb-9726-e8d005a48126
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	METFORMIN HYDROCHLORIDE
Proprietary Name Suffix	n/a
Non-Proprietary Name	METFORMIN HYDROCHLORIDE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	METFORMIN HYDROCHLORIDE
Labeler Name	Zydus Lifesciences Limited
Pharmaceutical Class	Biguanide [EPC], Biguanides [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077060
Listing Certified Through	2024-12-31

Package

Package Images

NDC 65841-0027-01 (65841002701)

Pricing Information	N/A
NDC Package Code	65841-027-01
Billing NDC	65841002701
Package	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-027-01)
Marketing Start Date	2005-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8a10ea0-7aa6-48ab-aad4-af8895636672 Details

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-027-05 in bottle of 500 tablets

Metformin Hydrochloride Extended-release Tablets USP, 500 mg

Rx only

500 tablets

NDC 65841-039-05 in bottle of 500 tablets

Metformin Hydrochloride Extended-release Tablets USP, 750 mg

Rx only

500 tablets

INGREDIENTS AND APPEARANCE

METFORMIN HYDROCHLORIDE

metformin hydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-027
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
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	63;Z
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-027-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
2	NDC:65841-027-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077060	09/28/2005

METFORMIN HYDROCHLORIDE

metformin hydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-039
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	750 mg

Ingredient Name	Strength
Inactive Ingredients
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	Z;C;20
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-039-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005
2	NDC:65841-039-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077078	09/28/2005

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-027, 65841-039) , MANUFACTURE(65841-027, 65841-039)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(65841-027, 65841-039) , MANUFACTURE(65841-027, 65841-039)

Revised: 11/2022

Document Id: 98157d0e-cac3-45cb-9726-e8d005a48126

Set id: a8a10ea0-7aa6-48ab-aad4-af8895636672

Version: 2

Effective Time: 20221105