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FDA Approval

Metformin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 051457844

Effective Date

January 17, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metformin(850 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Apotheca Inc.

DUNS Number

051457844

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Metformin Hydrochloride

Product Details

NDC Product Code

12634-757

Application Number

ANDA091184

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2017

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1

Metformin Hydrochloride

Product Details

NDC Product Code

12634-756

Application Number

ANDA091184

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2017

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

Metformin Hydrochloride

Product Details

NDC Product Code

12634-789

Application Number

ANDA091184

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2017

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

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