Home NDC 63629-1396 Metformin hydrochloride
Product NDC 63629-1396
11-digit product format 636291396
Labeler code 63629
Product ID 63629-1396_a6b741ce-124a-4066-9766-3137f9b4749f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA079148
Marketing category ANDA
Marketing start 2009-06-03
Marketing end 0000-00-00
Substance METFORMIN HYDROCHLORIDE
Active strength 850 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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A079148-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 A079148-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 A079148-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25
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 · 126 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 2026-08-18 06:07:40 2026-07 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079148-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2008-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079148-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2008-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079148-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2008-11-25 1e350fbaab3a…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-1396-1 63629139601 60 TABLET, FILM COATED in 1 BOTTLE (63629-1396-1) 2009-06-03 0000-00-00 No No Current 63629-1396-2 63629139602 30 TABLET, FILM COATED in 1 BOTTLE (63629-1396-2) 2009-06-03 0000-00-00 No No Current 63629-1396-3 63629139603 120 TABLET, FILM COATED in 1 BOTTLE (63629-1396-3) 2009-06-03 0000-00-00 No No Current 63629-1396-4 63629139604 90 TABLET, FILM COATED in 1 BOTTLE (63629-1396-4) 2009-06-03 0000-00-00 No No Current 63629-1396-5 63629139605 100 TABLET, FILM COATED in 1 BOTTLE (63629-1396-5) 2009-06-03 0000-00-00 No No Current 63629-1396-6 63629139606 180 TABLET, FILM COATED in 1 BOTTLE (63629-1396-6) 2009-06-03 0000-00-00 No No Current