Home NDC 62135-132 FLUCONAZOLE
Product NDC 62135-132
11-digit product format 621350132
Labeler code 62135
Product ID 62135-132_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 150 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.
Product history page 1 of 5 · 164 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 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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 150 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 62135-132-77 FLUCONAZOLE 1 in 1 BOTTLE TABLET 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-132 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 62135-132-77 62135013277 1 TABLET in 1 BOTTLE (62135-132-77) 1 tablet 2022-12-08 0000-00-00 No No Current