Home NDC 82009-174 METFORMIN HYDROCHLORIDE
Product NDC 82009-174
11-digit product format 820090174
Labeler code 82009
Product ID 82009-174_2d095382-d50c-4ae7-9d70-05a7c17eda06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METFORMIN HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Quallent Pharmaceuticals Health LLC
Application ANDA203686
Marketing category ANDA
Marketing start 2025-07-18
Substance METFORMIN HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A203686-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 A203686-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 A203686-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28
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 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203686-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2014-08-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203686-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2014-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203686-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2014-08-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base METFORMIN HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861004 Internal RxNorm lookup 861007 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82009-174-10 METFORMIN HYDROCHLORIDE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82009-174-10 82009017410 1000 TABLET, FILM COATED in 1 BOTTLE (82009-174-10) 2025-07-18 No No Current