Home NDC 0121-1091 Voriconazole
Product NDC 0121-1091
11-digit product format 001211091
Labeler code 0121
Product ID 0121-1091_942086e6-8d53-4ab9-b49c-c0234164ae91
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole Injection
Dosage form INJECTION
Route INTRAVENOUS
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA220043
Marketing category ANDA
Marketing start 2026-05-14
Substance VORICONAZOLE
Active strength 10 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 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 A220043-001 VORICONAZOLE VORICONAZOLE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2025-11-14
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 A220043-001 VORICONAZOLE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2025-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220043-001 VORICONAZOLE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2025-11-14 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220043-001 VORICONAZOLE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2025-11-14 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Voriconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORICONAZOLE 10 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 2727399 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 0121-1091-55 Voriconazole 1 in 1 CARTON INJECTION 1 2 0121-1091-55 Voriconazole 20 mL in 1 VIAL, SINGLE-USE INJECTION 20 2
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 Marketing start Sample Exclude flag Status 0121-1091-55 00121109155 1 VIAL, SINGLE-USE in 1 CARTON (0121-1091-55) / 20 mL in 1 VIAL, SINGLE-USE 2026-05-14 No No Current