Home NDC 51407-059-60 Metformin Hydrochloride
Product NDC 51407-059
Requested package NDC 51407-059-60
11-digit product format 514070059
Labeler code 51407
Product ID 51407-059_51cf63d6-cd26-0704-e063-6394a90afbc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metformin hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA203832
Marketing category ANDA
Marketing start 2017-12-26
Marketing end 2027-11-30
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203832-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26 A203832-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 of 3 · 86 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 2022-09-29 23:25 UTC 2022-09 A203832-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26 e64feba35796…2022-09-29 23:25 UTC 2022-09 A203832-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203832-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203832-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203832-001 METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203832-002 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB2 2017-12-26 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Metformin Hydrochloride 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807894 Internal RxNorm lookup 1807917 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 51407-059-60 Metformin Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED, EXTENDED RE 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-059 METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20240703_1cb2b2be-595c-4e72-8d2c-c1edc7f85682.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 51407-059-60 51407005960 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-059-60) 2018-03-12 2027-11-30 No No Current