Home NDC 70436-230 voriconazole
Product NDC 70436-230
11-digit product format 704360230
Labeler code 70436
Product ID 70436-230_3e5a72cf-40b2-0e01-e063-6294a90a698d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA216805
Marketing category ANDA
Marketing start 2024-03-01
Substance VORICONAZOLE
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 1 .
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 A216805-001 VORICONAZOLE VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216805-001 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 2026-02-19 14:30 UTC 2026-02 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216805-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2024-01-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base voriconazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORICONAZOLE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JFU09I87TR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 465355 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 70436-230-39 voriconazole 1 in 1 CARTON POWDER, FOR SUSPENSION 1 4 70436-230-39 voriconazole 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-230 VORICONAZOLE POWDER, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS, LLC] 3 Current NDC, 2 package rows 20250403_2b262849-9a29-44a2-9b9d-2378f771379c.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 70436-230-39 70436023039 1 BOTTLE in 1 CARTON (70436-230-39) / 75 mL in 1 BOTTLE 1 bottle 2024-03-01 No No Current