Home NDC 80425-0591 Metformin Hydrochloride
Product NDC 80425-0591
11-digit product format 804250591
Labeler code 80425
Product ID 80425-0591_5647163f-4654-233e-e063-6394a90a8fad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA075973
Marketing category ANDA
Marketing start 2026-07-10
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A075973-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 A075973-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 A075973-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25
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 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Metformin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METFORMIN HYDROCHLORIDE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861004 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80425-0591-1 80425059101 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-1) 2026-07-10 No No Current 80425-0591-2 80425059102 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-2) 2026-07-10 No No Current 80425-0591-3 80425059103 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-3) 2026-07-10 No No Current 80425-0591-4 80425059104 108 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-4) 2026-07-10 No No Current