Home NDC 42806-221-05 Metformin Hydrochloride
Product NDC 42806-221
Requested package NDC 42806-221-05
11-digit product format 428060221
Labeler code 42806
Product ID 42806-221_ac5505c5-6cb7-4918-8eb7-433923ff02ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA075965
Marketing category ANDA
Marketing start 2016-04-01
Marketing end 2023-08-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 A075965-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 A075965-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 A075965-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25
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 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075965-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075965-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075965-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 42806-221-05 42806022105 500 TABLET, FILM COATED in 1 BOTTLE (42806-221-05) 2016-04-01 0000-00-00 No No Current