Home NDC 68382-760 METFORMIN HYDROCHLORIDE
Product NDC 68382-760
11-digit product format 683820760
Labeler code 68382
Product ID 68382-760_ded2d979-09e7-4e52-b69d-b362bf3c1698
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METFORMIN HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA203686
Marketing category ANDA
Marketing start 2014-12-09
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 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 1000 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 68382-760-01 METFORMIN HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 15 68382-760-05 METFORMIN HYDROCHLORIDE 500 in 1 BOTTLE TABLET, FILM COATED 500 15 68382-760-10 METFORMIN HYDROCHLORIDE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 15 68382-760-16 METFORMIN HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 15 68382-760-30 METFORMIN HYDROCHLORIDE 1 in 1 BLISTER PACK TABLET, FILM COATED 1 15 68382-760-77 METFORMIN HYDROCHLORIDE 100 in 1 CARTON TABLET, FILM COATED 100 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 METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 GLYCERYL BEHENATE INACTIVE INGREDIENT R8WTH25YS2 METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 POVIDONE INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] 7 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-760 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 14 Current NDC, Legacy NDC, 6 package rows 20231110_c82a10fa-1e8e-46b6-890a-737de3f34ee1.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-760-01 68382076001 100 TABLET, FILM COATED in 1 BOTTLE (68382-760-01) 2014-12-09 0000-00-00 No No Current 68382-760-05 68382076005 500 TABLET, FILM COATED in 1 BOTTLE (68382-760-05) 2014-12-09 0000-00-00 No No Current 68382-760-10 68382076010 1000 TABLET, FILM COATED in 1 BOTTLE (68382-760-10) 2014-12-09 0000-00-00 No No Current 68382-760-16 68382076016 90 TABLET, FILM COATED in 1 BOTTLE (68382-760-16) 2014-12-09 0000-00-00 No No Current 68382-760-30 68382076030 1 in 1 BLISTER PACK Historical 68382-760-77 68382076077 100 BLISTER PACK in 1 CARTON (68382-760-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-760-30) 100 blister pack 2014-12-09 0000-00-00 No No Current