Home NDC 62135-680-60 Metformin Hydrochloride
Product NDC 62135-680
Requested package NDC 62135-680-60
11-digit product format 621350680
Labeler code 62135
Product ID 62135-680_52180966-60bd-3f94-e063-6394a90a0212
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA075972
Marketing category ANDA
Marketing start 2002-01-24
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075972-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-24 A075972-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-24 A075972-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-24 A075972-004 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET / ORAL AB 2002-01-24 A075972-005 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 625MG TABLET / ORAL AB 2002-01-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 2026-08-01 22:54:32 2026-06 A075972-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2002-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 A075972-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2002-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 A075972-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2002-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 A075972-004 METFORMIN HYDROCHLORIDE 750MG TABLET / ORAL AB 2002-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 A075972-005 METFORMIN HYDROCHLORIDE 625MG TABLET / ORAL AB 2002-01-24 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861004 Internal RxNorm lookup 861007 Internal RxNorm lookup 861010 Internal RxNorm lookup 861021 Internal RxNorm lookup 2703582 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 62135-680-05 Metformin Hydrochloride 500 in 1 BOTTLE TABLET 500 4 62135-680-10 Metformin Hydrochloride 1000 in 1 BOTTLE TABLET 1000 4 62135-680-18 Metformin Hydrochloride 180 in 1 BOTTLE TABLET 180 4 62135-680-60 Metformin Hydrochloride 60 in 1 BOTTLE TABLET 60 4 62135-680-90 Metformin Hydrochloride 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-680 METFORMIN HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 5 package rows 20231013_4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd.zip
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 62135-680-60 62135068060 60 TABLET in 1 BOTTLE (62135-680-60) 60 tablet 2022-04-06 0000-00-00 No No Current