Home NDC 65162-913 Voriconazole
Product NDC 65162-913
11-digit product format 651620913
Labeler code 65162
Product ID 65162-913_ac791850-702b-4495-9ff5-499c7b054c79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA205034
Marketing category ANDA
Marketing start 2013-11-29
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A205034-001 VORICONAZOLE VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205034-001 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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205034-001 VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB 2016-04-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Voriconazole
Listing expiration 2027-12-31 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 65162-913-22 Voriconazole 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-913 VORICONAZOLE POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS LLC] 22 Current NDC, Legacy NDC, 1 package rows 20231221_ed6624a9-0b73-4a21-bf13-a8add2081d02.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-913-22 65162091322 75 mL in 1 BOTTLE (65162-913-22) 75 ml 2013-11-29 0000-00-00 No No Current