Metformin Hydrochloride Extended-release Tablets, Usp

SPL v3

SPL

SPL Set ID a8a10ea0-7aa6-48ab-aad4-af8895636672

Route

ORAL

Published

Effective Date 2024-08-16

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Metformin (500 mg)

Inactive Ingredients

Glyceryl Behenate/eicosadioate Hypromelloses Povidone Cellulose, Microcrystalline Glyceryl Dibehenate

Identifiers & Packaging

Pill Appearance

Imprint: Z;C;20 Shape: capsule Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2005-09-28

Description

NDC 65841-027-10 in bottle of 1000 tablets Metformin Hydrochloride Extended-release Tablets USP, 500 mg Rx only 1000 tablets NDC 65841-039-01 in bottle of 100 tablets Metformin Hydrochloride Extended-release Tablets USP, 750 mg Rx only 100 tablets

Medication Information

Description

Package Label.principal Display Panel

NDC 65841-027-10 in bottle of 1000 tablets

Metformin Hydrochloride Extended-release Tablets USP, 500 mg

Rx only

1000 tablets

NDC 65841-039-01 in bottle of 100 tablets

Metformin Hydrochloride Extended-release Tablets USP, 750 mg

Rx only

100 tablets

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-027-10 in bottle of 1000 tablets

Metformin Hydrochloride Extended-release Tablets USP, 500 mg

Rx only

1000 tablets

NDC 65841-039-01 in bottle of 100 tablets

Metformin Hydrochloride Extended-release Tablets USP, 750 mg

Rx only

100 tablets

Advanced Ingredient Data

[{"name": "METFORMIN", "unii": "9100L32L2N", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GLYCERYL BEHENATE/EICOSADIOATE", "unii": "73CJJ317SR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METFORMIN", "unii": "9100L32L2N", "classCode": "ACTIB", "strengthNumerator": "750", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GLYCERYL DIBEHENATE", "unii": "R8WTH25YS2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-027-10 in bottle of 1000 tablets Metformin Hydrochloride Extended-release Tablets USP, 500 mg Rx only 1000 tablets NDC 65841-039-01 in bottle of 100 tablets Metformin Hydrochloride Extended-release Tablets USP, 750 mg Rx only 100 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:42:32.925351 · Updated: 2026-03-14T22:09:49.950257