Home NDC 70436-227 Fluconazole
Product NDC 70436-227
11-digit product format 704360227
Labeler code 70436
Product ID 70436-227_2c3342fa-abe7-d6b0-e063-6394a90ad1c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Slate Run Pharmaceuticals
Application ANDA215738
Marketing category ANDA
Marketing start 2024-01-01
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 2026-12-31
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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fluconazole
Listing expiration 2026-12-31 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 70436-227-48 Fluconazole 35 mL in 1 BOTTLE POWDER, FOR SUSPENSION 35 2 70436-227-48 Fluconazole 1 in 1 CARTON POWDER, FOR SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-227 FLUCONAZOLE POWDER, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS] 2 Current NDC, 2 package rows 20250122_13804efd-7cb3-431f-a6a7-bd6d1da5889e.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 70436-227-48 70436022748 1 BOTTLE in 1 CARTON (70436-227-48) / 35 mL in 1 BOTTLE 1 bottle 2024-01-01 No No Current