Fluconazole

Product NDC: 63187-613
11-digit product format: 631870613
Labeler code: 63187
Product ID: 63187-613_4a5d7cd0-63f5-4f16-b335-ad27a3c0b519
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076077
Marketing category: ANDA
Marketing start: 2004-07-29
Marketing end: 0000-00-00
Substance: FLUCONAZOLE
Active strength: 150 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: 2020-12-31
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	63187-613		D	Discontinued by firm		2026-10-12
excluded package	package	63187-613	63187-613-01	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.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-613-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-613-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A076077-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29
A076077-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29
A076077-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29
A076077-004	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A076077-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076077-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076077-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076077-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076077-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076077-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076077-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076077-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076077-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076077-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076077-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076077-004	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076077-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076077-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076077-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076077-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076077-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076077-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076077-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076077-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076077-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076077-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076077-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076077-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076077-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076077-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076077-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076077-004	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-613	FLUCONAZOLE TABLET [PROFICIENT RX LP]	3	Legacy NDC	20191121_b19e48e5-97c6-4b38-8721-8747b9c1a36a.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
63187-613-01	63187061301	1 TABLET in 1 BLISTER PACK (63187-613-01)	1 tablet	2018-12-01	0000-00-00	No	No	Current