Home NDC 43353-128-80 Metformin Hydrochloride
Product NDC 43353-128
Requested package NDC 43353-128-80
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 45 .
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 · 135 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 2026-11-14 07:37:17 2026-10 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091184-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2010-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091184-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2010-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091184-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2010-11-01 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-128-80 43353012880 180 TABLET, FILM COATED in 1 BOTTLE (43353-128-80) 2015-12-23 0000-00-00 No No Current