Home NDC 62135-133 FLUCONAZOLE
Product NDC 62135-133
11-digit product format 621350133
Labeler code 62135
Product ID 62135-133_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 200 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 42 .
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 · 168 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 2026-08-18 06:07:40 2026-07 A076665-001 FLUCONAZOLE 50MG TABLET / ORAL AB 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076665-002 FLUCONAZOLE 100MG TABLET / ORAL AB 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076665-003 FLUCONAZOLE 150MG TABLET / ORAL AB 2004-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076665-004 FLUCONAZOLE 200MG TABLET / ORAL AB 2004-07-29 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base FLUCONAZOLE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 200 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 62135-133-30 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 62135-133 FLUCONAZOLE TABLET [CHARTWELL RX, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241030_f86ea347-78f5-43b8-9574-a52569a4237b.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 · 3 matching rows.
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 62135-133-30 62135013330 30 TABLET in 1 BOTTLE (62135-133-30) 30 tablet 2022-12-08 0000-00-00 No No Current