Fluconazole

Product NDC: 16571-210
11-digit product format: 165710210
Labeler code: 16571
Product ID: 16571-210_c6266a40-1ceb-4dec-adc2-a118db7cd6e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA076957
Marketing category: ANDA
Marketing start: 2014-03-25
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16571-210		D	Discontinued by firm	2026-09-14
excluded package	package	16571-210	16571-210-10	D	Discontinued by firm	2026-09-14
excluded package	package	16571-210	16571-210-30	D	Discontinued by firm	2026-09-14

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 · 36 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	16571-210-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-210-10	`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	16571-210-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16571-210-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16571-210-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16571-210-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16571-210-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16571-210-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16571-210-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16571-210-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16571-210-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16571-210-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16571-210-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16571-210-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16571-210-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16571-210-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16571-210-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16571-210-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16571-210-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16571-210-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16571-210-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16571-210-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16571-210-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16571-210-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	TE codes	Approval date
A076957-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28
A076957-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28
A076957-003	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28
A076957-004	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076957-001	AB
A076957-002	AB
A076957-003	AB
A076957-004	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 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	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A076957-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076957-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-004	AB	1	`5bbf6a4d5a75…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16571-210-10	2024-02-22	Fluconazole Tablets, USP
16571-210-30	2024-02-22	Fluconazole Tablets, USP
16571-210-10	2024-01-30	Fluconazole Tablets, USP
16571-210-30	2024-01-30	Fluconazole Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-210-10	EA - Each	16571-210	7592d58e-3c2e-45a3-ac2a-00d6cccfd88d	1	2014-05-02
16571-210-30	EA - Each	16571-210	066de324-3938-4a78-be2c-38bfc485121c	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [PACK PHARMACEUTICALS, LLC]	3
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [PACK PHARMACEUTICALS, LLC]	3
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [PACK PHARMACEUTICALS, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [PACK PHARMACEUTICALS, LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [PACK PHARMACEUTICALS, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [PACK PHARMACEUTICALS, LLC]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FLUCONAZOLE TABLET [PACK PHARMACEUTICALS, LLC]	3

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
16571-210-10	16571021010	100 TABLET in 1 BOTTLE (16571-210-10)	100 tablet	2014-03-25	0000-00-00	No	No	Current
16571-210-30	16571021030	30 TABLET in 1 BOTTLE (16571-210-30)	30 tablet	2014-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets, USP	Rising Pharmaceuticals, Inc. \| Unique Pharmaceutical Laboratories	2017-12-13	Human Prescription Drug Label	6