Fluconazole

Product NDC: 85766-101
Requested package NDC: 85766-101-00
11-digit product format: 857660101
Labeler code: 85766
Product ID: 85766-101_5031f501-a03c-c192-e063-6294a90ae96c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA076658
Marketing category: ANDA
Marketing start: 2014-06-20
Substance: FLUCONAZOLE
Active strength: 50 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: 2027-12-31
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
A076658-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29
A076658-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29
A076658-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29
A076658-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076658-001	AB
A076658-002	AB
A076658-003	AB
A076658-004	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	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`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	A076658-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076658-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076658-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076658-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076658-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076658-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076658-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076658-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076658-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076658-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-004	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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUCONAZOLE	50 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
8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	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	SPL version
85766-101-00	Fluconazole	10 in 1 CARTON	TABLET	10	2
85766-101-00	Fluconazole	10 in 1 DOSE PACK	TABLET	10	2
85766-101-01	Fluconazole	100 in 1 BOTTLE	TABLET	100	2
85766-101-05	Fluconazole	500 in 1 BOTTLE	TABLET	500	2
85766-101-10	Fluconazole	10 in 1 BOTTLE	TABLET	10	2
85766-101-12	Fluconazole	12 in 1 BOTTLE	TABLET	12	2
85766-101-20	Fluconazole	20 in 1 BOTTLE	TABLET	20	2
85766-101-30	Fluconazole	30 in 1 BOTTLE	TABLET	30	2
85766-101-60	Fluconazole	60 in 1 BOTTLE	TABLET	60	2
85766-101-90	Fluconazole	90 in 1 BOTTLE	TABLET	90	2

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Cardinal Health 107, LLC	f1bfba3a-5b18-41c0-9084-b1f26bb93ef2	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658
Fluconazole	FLUCONAZOLE	Sportpharm LLC	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658 ndc (package): 85766-101-00 ndc (product): 85766-101 ndc11 (package): 85766010100
Fluconazole	FLUCONAZOLE	Major Pharmaceuticals	13184b13-e252-4b4d-a3e2-cfc4ad3d55b7	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658
Fluconazole	FLUCONAZOLE	Dr. Reddy's Laboratories Limited	d7fa1d79-4cd3-4a55-b74b-b31e82e616a3	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658
FLUCONAZOLE	FLUCONAZOLE	direct rx	b3db505a-9677-6f5a-e053-2a95a90a13d4	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	a499c43e-0454-4a8c-a547-31e9816babdd	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658

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
197698	fluconazole 100 MG Oral Tablet	PSN	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2
197699	fluconazole 150 MG Oral Tablet	PSN	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2
197700	fluconazole 200 MG Oral Tablet	PSN	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2
197701	fluconazole 50 MG Oral Tablet	PSN	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2
197698	fluconazole 100 MG Oral Tablet	SCD	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2
197699	fluconazole 150 MG Oral Tablet	SCD	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2
197700	fluconazole 200 MG Oral Tablet	SCD	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2
197701	fluconazole 50 MG Oral Tablet	SCD	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-101-00	85766010100	10 DOSE PACK in 1 CARTON (85766-101-00) / 10 TABLET in 1 DOSE PACK	10 dose pack	2025-10-10	No	No	Current