Home NDC 0093-7214 Metformin Hydrochloride
Product NDC 0093-7214
11-digit product format 000937214
Labeler code 0093
Product ID 0093-7214_fb4cc921-cebf-4294-87b7-df421d7e8892
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA075978
Marketing category ANDA
Marketing start 2003-04-17
Marketing end 2019-06-30
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 mg/1
Pharmacologic classes Biguanide [EPC],Biguanides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075978-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 A075978-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 A075978-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05
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 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075978-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075978-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075978-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 8072bd15b7f6…
Observed Orange Book normalized TE history# DailyMed Product Concepts# 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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] 1 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1
DailyMed RxNorm Mappings#