Voriconazole

Product NDC: 60687-979
11-digit product format: 606870979
Labeler code: 60687
Product ID: 60687-979_5a0c3a05-3abd-d337-e063-6394a90a9648
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Voriconazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA206837
Marketing category: ANDA
Marketing start: 2026-08-27
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206837-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2016-01-22
A206837-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2016-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206837-001	AB
A206837-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206837-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206837-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-01-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206837-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206837-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206837-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206837-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206837-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206837-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206837-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206837-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206837-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206837-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206837-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206837-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206837-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206837-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206837-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206837-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206837-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206837-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206837-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206837-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206837-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206837-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206837-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206837-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206837-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206837-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206837-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206837-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206837-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206837-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206837-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206837-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206837-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206837-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206837-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206837-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206837-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206837-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206837-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206837-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Voriconazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VORICONAZOLE	200 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c620b2d7-3c2b-4252-8cfc-2f322d624435	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voriconazole	VORICONAZOLE	American Health Packaging	c620b2d7-3c2b-4252-8cfc-2f322d624435	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206837 application number: ANDA206837 ndc (product): 60687-979
Voriconazole	VORICONAZOLE	Aurobindo Pharma Limited	4fe672ff-2cef-4f88-ab85-5a4b586da20d	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206837 application number: ANDA206837
Voriconazole	VORICONAZOLE	NorthStar Rx LLC	b38165a5-d8d4-4579-a49a-fbe92e764089	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206837 application number: ANDA206837

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	Sample	Exclude flag	Status
60687-979-21	60687097921	30 BLISTER PACK in 1 CARTON (60687-979-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-979-11)	30 blister pack	2026-08-27	No	No	Current