voriconazole

Product NDC: 40032-088
Requested package NDC: 40032-088-03
11-digit product format: 400320088
Labeler code: 40032
Product ID: 40032-088_a5c6201e-83da-448e-9a57-fd5c8a2d3751
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: voriconazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novel Laboratories, Inc.
Application: ANDA207371
Marketing category: ANDA
Marketing start: 2016-05-24
Marketing end: 0000-00-00
Substance: VORICONAZOLE
Active strength: 50 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: 2020-12-31
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	40032-088	40032-088-03	I	Inactivated by FDA		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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A207371-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2016-05-24
A207371-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2016-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207371-001	AB
A207371-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207371-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207371-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`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	A207371-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207371-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207371-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207371-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207371-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207371-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207371-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207371-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207371-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207371-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207371-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207371-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207371-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207371-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207371-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207371-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207371-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207371-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207371-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207371-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207371-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207371-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207371-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207371-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207371-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207371-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207371-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207371-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207371-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207371-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207371-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207371-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207371-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207371-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207371-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207371-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207371-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207371-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207371-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207371-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1f86875f-c0c9-343f-b96c-14093866e7a9	Product name	9	20190409
591c07fa-4d24-4cb9-9efc-86997c696aa7	Product name	1	20170602

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40032-088-03	2023-01-30	C162847	48780-1	f386c64a-0e48-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use VORICONAZOLE TABLETS safely and effectively. See full prescribing information for VORICONAZOLE TABLETS. VORICONAZOLE tablets for oral use Initial U.S. Approval: 2002
40032-088-05	2023-01-30	C162847	48780-1	f386c64a-0e48-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use VORICONAZOLE TABLETS safely and effectively. See full prescribing information for VORICONAZOLE TABLETS. VORICONAZOLE tablets for oral use Initial U.S. Approval: 2002
40032-088-31	2023-01-30	C162847	48780-1	f386c64a-0e48-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use VORICONAZOLE TABLETS safely and effectively. See full prescribing information for VORICONAZOLE TABLETS. VORICONAZOLE tablets for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
40032-088-03	voriconazole	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
40032-088-05	voriconazole	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
40032-088-30	voriconazole	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	3
40032-088-31	voriconazole	3 in 1 CARTON	TABLET, FILM COATED	3	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40032-088	VORICONAZOLE TABLET, FILM COATED [NOVEL LABORATORIES, INC.]	3	Legacy NDC, 4 package rows	20191221_c6b444dd-7ad9-4fb2-a444-2f3ece8a8353.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
voriconazole	VORICONAZOLE	Lupin Pharmaceuticals,Inc.	b4c934c0-c1bb-4b0a-bc32-fb9e77ef65fc	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207371 application number: ANDA207371

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349434	voriconazole 200 MG Oral Tablet	PSN	c6b444dd-7ad9-4fb2-a444-2f3ece8a8353	3
349435	voriconazole 50 MG Oral Tablet	PSN	c6b444dd-7ad9-4fb2-a444-2f3ece8a8353	3
349434	voriconazole 200 MG Oral Tablet	SCD	c6b444dd-7ad9-4fb2-a444-2f3ece8a8353	3
349435	voriconazole 50 MG Oral Tablet	SCD	c6b444dd-7ad9-4fb2-a444-2f3ece8a8353	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
40032-088-03	40032008803	30 TABLET, FILM COATED in 1 BOTTLE (40032-088-03)	2016-05-24	0000-00-00	No	No	Current