Home NDC 43353-128 Metformin Hydrochloride
Product NDC 43353-128
11-digit product format 433530128
Labeler code 43353
Product ID 43353-128_2ac9368a-7105-4d2a-a6d7-a8b9c5c9bfce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA091184
Marketing category ANDA
Marketing start 2011-01-31
Marketing end 0000-00-00
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 mg/1
Pharmacologic classes Biguanide [EPC],Biguanides [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A091184-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 A091184-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 A091184-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-128 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20160712_3395325a-35bd-4bda-bed3-81eb6153ed12.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-128-60 43353012860 90 TABLET, FILM COATED in 1 BOTTLE (43353-128-60) 2015-12-26 0000-00-00 No No Current 43353-128-80 43353012880 180 TABLET, FILM COATED in 1 BOTTLE (43353-128-80) 2015-12-23 0000-00-00 No No Current