Home NDC 62135-131 FLUCONAZOLE
Product NDC 62135-131
11-digit product format 621350131
Labeler code 62135
Product ID 62135-131_25892746-5194-5955-e063-6294a90a3b7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUCONAZOLE
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA076665
Marketing category ANDA
Marketing start 2004-07-29
Substance FLUCONAZOLE
Active strength 100 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076665-001 FLUCONAZOLE FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 A076665-002 FLUCONAZOLE FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 A076665-003 FLUCONAZOLE FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 A076665-004 FLUCONAZOLE FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base FLUCONAZOLE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8VZV102JFY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197698 Internal RxNorm lookup 197699 Internal RxNorm lookup 197700 Internal RxNorm lookup 197701 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 62135-131-30 FLUCONAZOLE 30 in 1 BOTTLE TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-131 FLUCONAZOLE TABLET [CHARTWELL RX, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241030_f86ea347-78f5-43b8-9574-a52569a4237b.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 62135-131-30 62135013130 30 TABLET in 1 BOTTLE (62135-131-30) 30 tablet 2022-12-08 0000-00-00 No No Current