Home NDC 43547-250 Metformin hydrochloride
Product NDC 43547-250
11-digit product format 435470250
Labeler code 43547
Product ID 43547-250_d1b2cf70-0b4c-4ed2-9064-5687c88d146f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Solco healthcare U.S., LLC
Application ANDA079148
Marketing category ANDA
Marketing start 2009-06-03
Marketing end 0000-00-00
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 mg/1
Pharmacologic classes Biguanide [EPC],Biguanides [CS]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 52 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43547-250-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43547-250-50 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43547-250-11 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43547-250-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43547-250-50 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43547-250-11 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43547-250-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43547-250-50 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43547-250-11 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43547-250-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43547-250-50 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43547-250-11 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43547-250-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43547-250-50 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43547-250-11 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43547-250-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43547-250-50 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43547-250-11 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43547-250-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43547-250-50 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43547-250-11 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43547-250-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43547-250-50 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43547-250-11 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43547-250-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43547-250-50 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43547-250-11 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43547-250-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43547-250-50 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43547-250-11 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43547-250-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43547-250-50 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43547-250-11 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43547-250-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43547-250-50 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43547-250-11 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43547-250-11 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43547-250-10 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43547-250-50 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# 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] 7 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] 4
DailyMed RxNorm Mappings#