Home NDC 0378-7185 Metformin Hydrochloride
Product NDC 0378-7185
11-digit product format 003787185
Labeler code 0378
Product ID 0378-7185_bd9cf158-94b6-42b0-b2d6-7d185b6ac310
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA075973
Marketing category ANDA
Marketing start 2010-06-03
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 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 A075973-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 A075973-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 A075973-003 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 · 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 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075973-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075973-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075973-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-25 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861004 Internal RxNorm lookup 861007 Internal RxNorm lookup 861010 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 0378-7185-05 Metformin Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 15
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 [MYLAN PHARMACEUTICALS INC.] 6 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 BLACKBERRY INACTIVE INGREDIENT 8A6OMU3I8L METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POVIDONE INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 BLACKBERRY INACTIVE INGREDIENT 8A6OMU3I8L METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-7185 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 14 Current NDC, Legacy NDC, 1 package rows 20240712_4f70f907-08d5-4c2e-a4be-32c6124faa7b.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-7185-05 00378718505 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7185-05) 2010-06-03 0000-00-00 No No Current