Home NDC 0904-6326 Metformin Hydrochloride
Product NDC 0904-6326
11-digit product format 009046326
Labeler code 0904
Product ID 0904-6326_23fc3846-af9d-486f-bd6d-a3a040191602
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA091184
Marketing category ANDA
Marketing start 2011-01-31
Marketing end 0000-00-00
Substance METFORMIN HYDROCHLORIDE
Active strength 500 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-6326-61 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-6326-61 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0904-6326-61 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0904-6326-61 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0904-6326-61 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0904-6326-61 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-6326-61 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-6326-61 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-6326-61 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0904-6326-61 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0904-6326-61 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0904-6326-61 557ba5c1ecfa…9c80585c8c6e…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH] 2 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1
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 0904-6326-61 00904632661 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6326-61) 2011-01-31 0000-00-00 No No Current