Home DailyMed fb9bfe96-21a4-40df-8fd9-7f00856f1b65 Metformin hydrochloride Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Northwind Pharmaceuticals
Effective date 2014-06-06
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source legacy-cache
Hydrated at 2026-08-02 01:36:03 Label at a glance# Product Metformin hydrochloride
Active ingredient METFORMIN HYDROCHLORIDE
Label structure 1 sections
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-560 METFORMIN HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS] 1 Legacy NDC 20140606_fb9bfe96-21a4-40df-8fd9-7f00856f1b65.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII SPL version Uploaded METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E 1 METFORMIN ACTIVE MOIETY 9100L32L2N 1
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 2 matching rows.
Metformin hydrochloride METFORMIN Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 1 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090564-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 A090564-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 A090564-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090564-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090564-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2010-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090564-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-04-22 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
