Fluconazole

Product NDC: 57237-006
11-digit product format: 572370006
Labeler code: 57237
Product ID: 57237-006_1018b9ad-7145-49b4-903a-b483797d7c86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA077731
Marketing category: ANDA
Marketing start: 2008-10-07
Substance: FLUCONAZOLE
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: 2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077731-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07
A077731-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07
A077731-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07
A077731-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077731-001	AB
A077731-002	AB
A077731-003	AB
A077731-004	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	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2008-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2008-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2008-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2008-10-07	`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	A077731-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077731-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077731-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077731-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077731-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077731-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077731-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077731-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077731-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077731-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077731-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077731-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077731-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077731-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077731-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077731-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077731-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077731-004	AB	1	`5bbf6a4d5a75…`

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: Fluconazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUCONAZOLE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8VZV102JFY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197698	Internal RxNorm lookup
197699	Internal RxNorm lookup
197700	Internal RxNorm lookup
197701	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
2ca7efcd-4a8d-4139-a3eb-930afd18b13f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648	Product name	2	20250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-006-01	Fluconazole	100 in 1 BOTTLE	TABLET	100		17
57237-006-30	Fluconazole	30 in 1 BOTTLE	TABLET	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-006-01	EA - Each	57237-006	ebc76df8-44fd-4bb4-ad60-331c12eeffab	1	2022-02-07
57237-006-30	EA - Each	57237-006	b2de94c1-2f4e-4158-8aca-5409ca68cb96	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	FLUCONAZOLE TABLET [CITRON PHARMA LLC]	4
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-006	FLUCONAZOLE TABLET [RISING PHARMA HOLDINGS, INC.]	17	Current NDC, Legacy NDC, 2 package rows	20240822_2ca7efcd-4a8d-4139-a3eb-930afd18b13f.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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fef2222c-5d61-435e-8761-d8f3d435d6d8	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	American Health Packaging	d7aacee3-9d9c-4b36-b735-39bcb9edf941	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	90538767-c84b-4637-8ab6-8c147315eafa	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	fd7ea788-29b7-1f0b-e053-6394a90a2980	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	0aacafca-baf8-9a22-e063-6394a90a2ca9	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Direct_Rx	06f8f4b9-5289-2d59-e063-6294a90a7209	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	068623f9-0f87-50bc-e063-6294a90aea00	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals, Inc.	2b9b08b6-7239-473b-e063-6294a90ab7c4	2025-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	177322f4-9526-40cb-9e5d-bc24e8fb02db	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Aurobindo Pharma Limited	6ebf24fd-41cd-4b3c-8176-a1436253ba2d	2024-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Proficient Rx LP	4eaf5b04-c026-4a49-879f-2925b375f903	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	3f743514-615e-4e78-8321-24c545a7752f	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NorthStar Rx LLC	d2acccda-8068-46c1-8562-950d7f70ee06	2024-07-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Rising Pharma Holdings, Inc.	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	2024-07-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731 ndc (product): 57237-006
Fluconazole	FLUCONAZOLE	Pharmasource Meds, LLC	fe0cc56d-c0b6-f859-e053-6294a90ad932	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Proficient Rx LP	88d9904c-0c21-4188-95e2-6479bdf359df	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197700	fluconazole 200 MG Oral Tablet	PSN	3f743514-615e-4e78-8321-24c545a7752f	102
197700	fluconazole 200 MG Oral Tablet	SCD	3f743514-615e-4e78-8321-24c545a7752f	102
197698	fluconazole 100 MG Oral Tablet	PSN	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197699	fluconazole 150 MG Oral Tablet	PSN	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197700	fluconazole 200 MG Oral Tablet	PSN	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197701	fluconazole 50 MG Oral Tablet	PSN	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197698	fluconazole 100 MG Oral Tablet	SCD	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197699	fluconazole 150 MG Oral Tablet	SCD	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197700	fluconazole 200 MG Oral Tablet	SCD	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197701	fluconazole 50 MG Oral Tablet	SCD	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	17
197698	fluconazole 100 MG Oral Tablet	PSN	d7aacee3-9d9c-4b36-b735-39bcb9edf941	12
197700	fluconazole 200 MG Oral Tablet	PSN	d7aacee3-9d9c-4b36-b735-39bcb9edf941	12
197698	fluconazole 100 MG Oral Tablet	SCD	d7aacee3-9d9c-4b36-b735-39bcb9edf941	12
197700	fluconazole 200 MG Oral Tablet	SCD	d7aacee3-9d9c-4b36-b735-39bcb9edf941	12
197698	fluconazole 100 MG Oral Tablet	PSN	551a5c8f-57eb-2643-12c6-7c700584b49f	10
197700	fluconazole 200 MG Oral Tablet	PSN	551a5c8f-57eb-2643-12c6-7c700584b49f	10
197698	fluconazole 100 MG Oral Tablet	SCD	551a5c8f-57eb-2643-12c6-7c700584b49f	10
197700	fluconazole 200 MG Oral Tablet	SCD	551a5c8f-57eb-2643-12c6-7c700584b49f	10
197700	fluconazole 200 MG Oral Tablet	PSN	726daf35-4c03-464f-a814-cc0a715d6031	5
197700	fluconazole 200 MG Oral Tablet	PSN	c6be26bb-af92-405b-9908-972d6e985cf0	5
197700	fluconazole 200 MG Oral Tablet	SCD	726daf35-4c03-464f-a814-cc0a715d6031	5
197700	fluconazole 200 MG Oral Tablet	SCD	c6be26bb-af92-405b-9908-972d6e985cf0	5
197700	fluconazole 200 MG Oral Tablet	PSN	eeeb82e1-d668-418e-9716-f8bcf72f80c0	4
197700	fluconazole 200 MG Oral Tablet	SCD	eeeb82e1-d668-418e-9716-f8bcf72f80c0	4
197698	fluconazole 100 MG Oral Tablet	PSN	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197699	fluconazole 150 MG Oral Tablet	PSN	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197700	fluconazole 200 MG Oral Tablet	PSN	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197700	fluconazole 200 MG Oral Tablet	PSN	fd7ea788-29b7-1f0b-e053-6394a90a2980	2
197700	fluconazole 200 MG Oral Tablet	PSN	fef2222c-5d61-435e-8761-d8f3d435d6d8	2
197700	fluconazole 200 MG Oral Tablet	PSN	0aacafca-baf8-9a22-e063-6394a90a2ca9	2
197700	fluconazole 200 MG Oral Tablet	PSN	06f8f4b9-5289-2d59-e063-6294a90a7209	2
197701	fluconazole 50 MG Oral Tablet	PSN	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197698	fluconazole 100 MG Oral Tablet	SCD	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197699	fluconazole 150 MG Oral Tablet	SCD	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197700	fluconazole 200 MG Oral Tablet	SCD	fd7ea788-29b7-1f0b-e053-6394a90a2980	2
197700	fluconazole 200 MG Oral Tablet	SCD	fef2222c-5d61-435e-8761-d8f3d435d6d8	2
197700	fluconazole 200 MG Oral Tablet	SCD	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197700	fluconazole 200 MG Oral Tablet	SCD	0aacafca-baf8-9a22-e063-6394a90a2ca9	2
197700	fluconazole 200 MG Oral Tablet	SCD	06f8f4b9-5289-2d59-e063-6294a90a7209	2
197701	fluconazole 50 MG Oral Tablet	SCD	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2
197698	fluconazole 100 MG Oral Tablet	PSN	98ac5455-d26c-4780-a5a3-bf8d85917626	1
197699	fluconazole 150 MG Oral Tablet	PSN	98ac5455-d26c-4780-a5a3-bf8d85917626	1
197700	fluconazole 200 MG Oral Tablet	PSN	98ac5455-d26c-4780-a5a3-bf8d85917626	1
197701	fluconazole 50 MG Oral Tablet	PSN	98ac5455-d26c-4780-a5a3-bf8d85917626	1
197698	fluconazole 100 MG Oral Tablet	SCD	98ac5455-d26c-4780-a5a3-bf8d85917626	1
197699	fluconazole 150 MG Oral Tablet	SCD	98ac5455-d26c-4780-a5a3-bf8d85917626	1
197700	fluconazole 200 MG Oral Tablet	SCD	98ac5455-d26c-4780-a5a3-bf8d85917626	1
197701	fluconazole 50 MG Oral Tablet	SCD	98ac5455-d26c-4780-a5a3-bf8d85917626	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-006-01	57237000601	100 TABLET in 1 BOTTLE (57237-006-01)	100 tablet	2008-10-07	0000-00-00	No	No	Current
57237-006-30	57237000630	30 TABLET in 1 BOTTLE (57237-006-30)	30 tablet	2008-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets USP Rx only	REMEDYREPACK INC.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	6
Fluconazole Tablets USP Rx only	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	2
Fluconazole Tablets USP Rx only	Preferred Pharmaceuticals Inc.	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	4
Fluconazole Tablets USP Rx only	Sportpharm LLC	2026-02-09	HUMAN PRESCRIPTION DRUG LABEL	1
Fluconazole Tablets USP Rx only	AvPAK	2026-01-06	HUMAN PRESCRIPTION DRUG LABEL	10
Fluconazole Tablets USP Rx only	A-S Medication Solutions	2025-12-01	Human Prescription Drug Label	5
Fluconazole Tablets USP Rx only	Proficient Rx LP	2025-09-01	HUMAN PRESCRIPTION DRUG LABEL	2
Fluconazole Tablets USP 8272801/0525(F) Rx only	American Health Packaging	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	12
Fluconazole Tablets USP Rx only	NuCare Pharmaceuticals,Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	2
Fluconazole Tablets USP Rx only	NuCare Pharmaceuticals,Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	2
Fluconazole	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Fluconazole Tablets USP Rx only	Bryant Ranch Prepack	2024-09-06	HUMAN PRESCRIPTION DRUG LABEL	102
Fluconazole Tablets USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-07-04	Human Prescription Drug Label	17