Home NDC 62135-160 Gemfibrozil
Product NDC 62135-160
11-digit product format 621350160
Labeler code 62135
Product ID 62135-160_2589e155-f097-67fc-e063-6294a90a20b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemfibrozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA074270
Marketing category ANDA
Marketing start 1993-09-27
Substance GEMFIBROZIL
Active strength 600 mg/1
Pharmacologic classes PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074270-001 GEMFIBROZIL GEMFIBROZIL 600MG TABLET / ORAL AB 1993-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074270-001 AB
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 A074270-001 GEMFIBROZIL 600MG TABLET / ORAL AB 1993-09-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A074270-001 AB 1 a50c72e98297…
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Gemfibrozil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMFIBROZIL 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q8X02027X3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310459 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 62135-160-31 Gemfibrozil 300 in 1 BOTTLE TABLET, FILM COATED 300 3 62135-160-60 Gemfibrozil 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-160 GEMFIBROZIL TABLET, FILM COATED [CHARTWELL RX, LLC] 3 Current NDC, 2 package rows 20241030_b8bb442e-66dc-435e-830c-4ba3daa47c04.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-160-31 62135016031 300 TABLET, FILM COATED in 1 BOTTLE (62135-160-31) 2023-08-25 No No Current 62135-160-60 62135016060 60 TABLET, FILM COATED in 1 BOTTLE (62135-160-60) 2023-08-25 No No Current