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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

American Health Packaging

DUNS: 929561009

Effective Date

August 30, 2023

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.

American Health Packaging

Labeler

American Health Packaging

DUNS Number

929561009

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

60687-143

Application Number

ANDA203686

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 30, 2023

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MetforminActive

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

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Metformin Hydrochloride

Product Details

NDC Product Code

60687-155

Application Number

ANDA203686

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 30, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

MetforminActive

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

Metformin Hydrochloride

Product Details

NDC Product Code

60687-162

Application Number

ANDA203686

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 30, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MetforminActive

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

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