Home NDC 68462-572 voriconazole
Product NDC 68462-572
11-digit product format 684620572
Labeler code 68462
Product ID 68462-572_1c47b796-6b3e-4321-86f6-f51fbf9a39fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA203503
Marketing category ANDA
Marketing start 2015-09-04
Marketing end 2026-11-01
Substance VORICONAZOLE
Active strength 50 mg/1
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
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203503-001 VORICONAZOLE VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 A203503-002 VORICONAZOLE VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203503-001 VORICONAZOLE 50MG TABLET / ORAL AB 2015-09-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203503-002 VORICONAZOLE 200MG TABLET / ORAL AB 2015-09-02 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base voriconazole Active Ingredients# Ingredient, Strength table Ingredient Strength VORICONAZOLE 50 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349434 Internal RxNorm lookup 349435 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 68462-572-13 voriconazole 3 in 1 CARTON TABLET, FILM COATED 3 17 68462-572-13 voriconazole 10 in 1 BLISTER PACK TABLET, FILM COATED 10 17 68462-572-30 voriconazole 30 in 1 BOTTLE TABLET, FILM COATED 30 17 68462-572-90 voriconazole 90 in 1 BOTTLE TABLET, FILM COATED 90 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-572 VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 16 Current NDC, Legacy NDC, 4 package rows 20250418_4cbac6ad-0faa-4181-a830-27a9f1536b7a.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 Marketing end Sample Exclude flag Status 68462-572-13 68462057213 3 BLISTER PACK in 1 CARTON (68462-572-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2015-09-04 2026-11-01 No No Current 68462-572-30 68462057230 30 TABLET, FILM COATED in 1 BOTTLE (68462-572-30) 2015-09-04 2026-11-01 No No Current 68462-572-90 68462057290 90 TABLET, FILM COATED in 1 BOTTLE (68462-572-90) 2015-09-04 2026-11-01 No No Current