voriconazole

Product NDC: 65841-831
Requested package NDC: 65841-831-16
11-digit product format: 658410831
Labeler code: 65841
Product ID: 65841-831_7666344f-3ba8-4a08-a828-65b846868dc0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: voriconazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA206747
Marketing category: ANDA
Marketing start: 2016-05-25
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
A206747-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2016-05-24
A206747-002	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
A206747-001	AB
A206747-002	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	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`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	A206747-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206747-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206747-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206747-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206747-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206747-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206747-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206747-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206747-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206747-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206747-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206747-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206747-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206747-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206747-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206747-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206747-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206747-002	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
bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-831-01	voriconazole	100 in 1 BOTTLE	TABLET, FILM COATED	100	17
65841-831-05	voriconazole	500 in 1 BOTTLE	TABLET, FILM COATED	500	17
65841-831-06	voriconazole	30 in 1 BOTTLE	TABLET, FILM COATED	30	17
65841-831-10	voriconazole	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	17
65841-831-16	voriconazole	90 in 1 BOTTLE	TABLET, FILM COATED	90	17
65841-831-30	voriconazole	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	17
65841-831-77	voriconazole	10 in 1 CARTON	TABLET, FILM COATED	10	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-831	VORICONAZOLE TABLET [ZYDUS LIFESCIENCES LIMITED]	14	Current NDC, Legacy NDC, 7 package rows	20250430_bda70104-d84b-4d3f-9ca0-5f4f1ca816ad.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
voriconazole	VORICONAZOLE	Major Pharmaceuticals	49dcf3ae-6d6b-46fe-a88e-ec65f2de332e	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206747 application number: ANDA206747
voriconazole	VORICONAZOLE	Viona Pharmaceuticals Inc	75fcbea8-8eeb-4528-b7d9-a059dd25da83	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206747 application number: ANDA206747
voriconazole	VORICONAZOLE	Zydus Lifesciences Limited	bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206747 application number: ANDA206747 ndc (package): 65841-831-16 ndc (product): 65841-831 ndc11 (package): 65841083116

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	bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	17
349435	voriconazole 50 MG Oral Tablet	PSN	bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	17
349434	voriconazole 200 MG Oral Tablet	SCD	bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	17
349435	voriconazole 50 MG Oral Tablet	SCD	bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-831-16	65841083116	90 TABLET, FILM COATED in 1 BOTTLE (65841-831-16)	2016-05-25	0000-00-00	No	No	Current