Voriconazole

Product NDC: 59762-0930
Requested package NDC: 59762-0930-2
11-digit product format: 597620930
Labeler code: 59762
Product ID: 59762-0930_07740108-03ca-49ac-aecb-24a1efa8fd0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Voriconazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Greenstone LLC
Application: NDA021266
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-07-08
Marketing end: 0000-00-00
Substance: VORICONAZOLE
Active strength: 200 mg/1
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59762-0930	59762-0930-2	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021266-001	VFEND	VORICONAZOLE	50MG	TABLET / ORAL	AB	RLD	2002-05-24
N021266-002	VFEND	VORICONAZOLE	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021266-001	AB
N021266-002	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 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	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021266-001	VFEND	50MG	TABLET / ORAL	AB	RLD	2002-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021266-002	VFEND	200MG	TABLET / ORAL	AB	RLD, RS	2002-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021266-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021266-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021266-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021266-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021266-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021266-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021266-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021266-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021266-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021266-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021266-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021266-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021266-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021266-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021266-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021266-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021266-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021266-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021266-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021266-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021266-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021266-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021266-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021266-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021266-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021266-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021266-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021266-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021266-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021266-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021266-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021266-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021266-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021266-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021266-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021266-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021266-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021266-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021266-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021266-002	AB	1	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021266-001	NPP	2022-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021266-002	NPP	2022-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021266-001	NPP	2022-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021266-002	NPP	2022-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021266-001	NPP	2022-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021266-002	NPP	2022-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021266-001	NPP	2022-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021266-002	NPP	2022-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021266-001	NPP	2022-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021266-002	NPP	2022-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021266-001	NPP	2022-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021266-002	NPP	2022-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021266-001	NPP	2022-01-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021266-002	NPP	2022-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021266-001	NPP	2022-01-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021266-002	NPP	2022-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021266-001	NPP	2022-01-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021266-002	NPP	2022-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021266-001	NPP	2022-01-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021266-002	NPP	2022-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021266-001	NPP	2022-01-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021266-002	NPP	2022-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021266-001	NPP	2022-01-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021266-002	NPP	2022-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021266-001	NPP	2022-01-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021266-002	NPP	2022-01-29	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021266-001	NPP	2022-01-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021266-002	NPP	2022-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021266-001	NPP	2022-01-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021266-002	NPP	2022-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021266-001	NPP	2022-01-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021266-002	NPP	2022-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021266-001	NPP	2022-01-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021266-002	NPP	2022-01-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021266-001	NPP	2022-01-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021266-002	NPP	2022-01-29	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-0930-2	EA - Each	59762-0930	6591b43e-6f82-4c36-b3dc-73eeb7039e40	1	2012-07-24

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VFEND	VORICONAZOLE	Roerig	ce3ef5cf-3087-4d92-9d94-9eb8287228db	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021266 application number: NDA021266

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JFU09I87TR	VORICONAZOLE	137234-62-9	VORICONAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-0930-2	59762093002	30 TABLET, FILM COATED in 1 BOTTLE (59762-0930-2)	2010-07-08	0000-00-00	No	No	Current