Voriconazole

Product NDC: 63739-008
11-digit product format: 637390008
Labeler code: 63739
Product ID: 63739-008_d9a968b0-4d04-1cea-e053-2a95a90a444b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Voriconazole
Dosage form: TABLET
Route: ORAL
Labeler: Mckesson Corporation DBA SKY Packaginng
Application: ANDA206181
Marketing category: ANDA
Marketing start: 2016-05-31
Marketing end: 0000-00-00
Substance: VORICONAZOLE
Active strength: 200 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
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-008		D	Discontinued by firm		2026-08-11
excluded package	package	63739-008	63739-008-33	D	Discontinued by firm		2026-08-11

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
A206181-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2016-05-24
A206181-002	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
A206181-001	AB
A206181-002	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	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206181-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206181-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206181-002	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	A206181-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206181-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206181-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206181-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206181-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206181-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206181-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206181-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206181-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206181-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206181-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206181-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206181-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206181-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206181-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206181-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206181-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206181-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206181-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206181-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206181-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206181-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206181-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206181-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206181-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206181-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206181-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206181-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206181-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206181-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206181-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206181-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206181-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206181-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206181-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206181-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206181-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206181-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206181-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206181-002	AB	1	`782e0a99824c…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-008	VORICONAZOLE TABLET [MCKESSON CORPORATION DBA SKY PACKAGINNG]	8	Legacy NDC	20250115_aa18d6fa-8a5c-4c69-b4db-6ae578165d7d.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voriconazole	VORICONAZOLE	Major Pharmaceuticals	796cad15-2aef-4823-917d-17b822a6916e	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206181 application number: ANDA206181
Voriconazole	VORICONAZOLE	Ajanta Pharma USA Inc.	16a80777-f1f3-45bb-a312-998b07767fe3	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206181 application number: ANDA206181

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-008-33	63739000833	3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-008-33) > 10 TABLET in 1 BLISTER PACK	3 blister pack	2016-05-31	0000-00-00	No	No	Current