Voriconazole

Product NDC: 60687-294
Requested package NDC: 60687-294-21
11-digit product format: 606870294
Labeler code: 60687
Product ID: 60687-294_d4eece4a-8db0-28bb-e053-2995a90a8501
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Voriconazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA203503
Marketing category: ANDA
Marketing start: 2018-02-21
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60687-294	60687-294-21	D	Discontinued by firm		2026-10-05

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
A203503-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2015-09-02
A203503-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2015-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203503-001	AB
A203503-002	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	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`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	A203503-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203503-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203503-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203503-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203503-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203503-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203503-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203503-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203503-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203503-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203503-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203503-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203503-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203503-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203503-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203503-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203503-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203503-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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	Strength	SPL version
60687-294-11	Voriconazole	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		9
60687-294-21	Voriconazole	30 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-294-11	EA - Each	60687-294	016a3e68-03ba-44ef-83d6-f79e20a59497	1	2018-04-19
60687-294-21	EA - Each	60687-294	d15dc9f1-5a9b-491e-ab4a-01ce7f3a0671	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-294	VORICONAZOLE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	8	Legacy NDC, 2 package rows	20240913_8379ac92-53cd-46db-8642-017f11830a86.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	American Health Packaging	8379ac92-53cd-46db-8642-017f11830a86	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203503 application number: ANDA203503 ndc (package): 60687-294-21 ndc (product): 60687-294 ndc11 (package): 60687029421
voriconazole	VORICONAZOLE	Glenmark Pharmaceuticals Inc., USA	4cbac6ad-0faa-4181-a830-27a9f1536b7a	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203503 application number: ANDA203503

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	8379ac92-53cd-46db-8642-017f11830a86	9
349435	voriconazole 50 MG Oral Tablet	PSN	8379ac92-53cd-46db-8642-017f11830a86	9
349434	voriconazole 200 MG Oral Tablet	SCD	8379ac92-53cd-46db-8642-017f11830a86	9
349435	voriconazole 50 MG Oral Tablet	SCD	8379ac92-53cd-46db-8642-017f11830a86	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-294-21	60687029421	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-294-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-294-11)	30 blister pack	2018-02-21	0000-00-00	No	No	Current