Home NDC 72673-091 Fluconazole
Product NDC 72673-091
11-digit product format 726730091
Labeler code 72673
Product ID 72673-091_47d8769c-b294-65ab-e063-6394a90a8bff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Zhejiang Poly Pharm. Co., Ltd.
Application ANDA215738
Marketing category ANDA
Marketing start 2025-04-01
Substance FLUCONAZOLE
Active strength 40 mg/mL
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A215738-001 FLUCONAZOLE FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215738-001 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 2026-09-14 22:38:34 2026-08 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215738-001 FLUCONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2023-09-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fluconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCONAZOLE 40 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310353 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 72673-091-14 Fluconazole 1 in 1 CARTON POWDER, FOR SUSPENSION 1 2 72673-091-14 Fluconazole 35 mL in 1 BOTTLE POWDER, FOR SUSPENSION 35 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72673-091 FLUCONAZOLE POWDER, FOR SUSPENSION [ZHEJIANG POLY PHARM. CO., LTD.] 1 Current NDC, 2 package rows 20250402_2a3ba181-5baa-5942-e063-6294a90a82b2.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72673-091-14 72673009114 1 BOTTLE in 1 CARTON (72673-091-14) / 35 mL in 1 BOTTLE 1 bottle 2025-04-01 No No Current