Metformin Hydrochloride Tablets

SPL v14

SPL

SPL Set ID 5043d03e-3c9d-4c96-b48d-187f02a1d27c

Route

ORAL

Published

Effective Date 2024-07-29

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Metformin (500 mg)

Inactive Ingredients

Hypromelloses Magnesium Stearate Polyethylene Glycol, Unspecified Povidone Cellulose, Microcrystalline Silicon Dioxide Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: Z;71 Shape: round Shape: oval Color: white Size: 13 mm Size: 19 mm Score: 2

Marketing Status

ANDA Active Since 2014-12-09

Description

NDC 65841-809-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 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 65841-811-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets

Medication Information

Description

Package Label.principal Display Panel

NDC 65841-809-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 500 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 65841-811-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 1000 mg

Rx only

100 tablets

Structured Label Content

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

NDC 65841-809-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 500 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 65841-811-01 in bottle of 100 tablets

Metformin Hydrochloride Tablets USP, 1000 mg

Rx only

100 tablets

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-809-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 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 65841-811-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:44:03.637060 · Updated: 2026-03-14T22:18:33.371936