Home NDC 68083-321 Voriconazole
Product NDC 68083-321
11-digit product format 680830321
Labeler code 68083
Product ID 68083-321_9f57066e-9301-4770-87df-29a62a42decc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA211099
Marketing category ANDA
Marketing start 2020-03-31
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 A211099-001 VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP 2020-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211099-001 AP
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 A211099-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP 2020-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211099-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP 2020-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211099-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2020-03-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211099-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP 2020-03-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 351209 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 68083-321-01 Voriconazole 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 16 68083-321-01 Voriconazole 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-321 VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 15 Current NDC, Legacy NDC, 2 package rows 20250514_9d5b9457-ac38-4f17-854d-e394c00e273c.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 Marketing start Marketing end Sample Exclude flag Status 68083-321-01 68083032101 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-321-01) / 20 mL in 1 VIAL, SINGLE-DOSE 2020-03-31 0000-00-00 No No Current