Home NDC 43063-507 METFORMIN HYDROCHLORIDE
Product NDC 43063-507
11-digit product format 430630507
Labeler code 43063
Product ID 43063-507_97cad7a2-7173-a1a7-e053-2a95a90ae6af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METFORMIN HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA077064
Marketing category ANDA
Marketing start 2005-09-28
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 44 .
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 A077064-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 A077064-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 A077064-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18
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 · 132 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 2026-10-15 13:18:30 2026-09 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077064-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2005-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077064-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2005-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077064-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2005-04-18 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [PD-RX PHARMACEUTICALS, INC.] 8 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 POVIDONE INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8