Fluconazole

Product NDC: 51672-4064
11-digit product format: 516724064
Labeler code: 51672
Product ID: 51672-4064_8d540365-1548-467f-9701-a84829a7d086
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA076507
Marketing category: ANDA
Marketing start: 2004-07-29
Marketing end: 0000-00-00
Substance: FLUCONAZOLE
Active strength: 50 mg/1
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-4064		D	Discontinued by firm	2026-10-12
excluded package	package	51672-4064	51672-4064-0	D	Discontinued by firm	2026-10-12
excluded package	package	51672-4064	51672-4064-3	D	Discontinued by firm	2026-10-12
excluded package	package	51672-4064	51672-4064-6	D	Discontinued by firm	2026-10-12

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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	51672-4064-0
excluded package	package	51672-4064-3
excluded package	package	51672-4064-6

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076507-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29
A076507-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29
A076507-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29
A076507-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29

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 5 · 172 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	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL		2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL		2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL		2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL		2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL		2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL		2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL		2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL		2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL		2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL		2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL		2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL		2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL		2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL		2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL		2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL		2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076507-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076507-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076507-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076507-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076507-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076507-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076507-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076507-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076507-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076507-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076507-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076507-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076507-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076507-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076507-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076507-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076507-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076507-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076507-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076507-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076507-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076507-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076507-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076507-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076507-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076507-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076507-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076507-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076507-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076507-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076507-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076507-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076507-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076507-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076507-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076507-004	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluconazole	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Fluconazole	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
calcium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
d&c red no. 6	INACTIVE INGREDIENT	481744AI4O	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
fd&c red no. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4064	FLUCONAZOLE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8	Legacy NDC	20241211_4d7cf836-d115-456c-a636-6f05eae043cd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8VZV102JFY	FLUCONAZOLE	86386-73-4	FLUCONAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4064-0	51672406400	10 BLISTER PACK in 1 CARTON (51672-4064-0) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2004-07-29	0000-00-00	No	No	Current
51672-4064-3	51672406403	1000 TABLET in 1 BOTTLE (51672-4064-3)	1000 tablet	2004-07-29	0000-00-00	No	No	Current
51672-4064-6	51672406406	30 TABLET in 1 BOTTLE (51672-4064-6)	30 tablet	2004-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets, USP	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries Ltd.	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	8