FLUCONAZOLE

Product NDC: 85534-0049
11-digit product format: 855340049
Labeler code: 85534
Product ID: 85534-0049_55adedaa-a28a-27e3-e063-6394a90a63ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUCONAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA076665
Marketing category: ANDA
Marketing start: 2004-07-29
Substance: FLUCONAZOLE
Active strength: 150 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
A076665-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29
A076665-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29
A076665-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29
A076665-004	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
A076665-001	AB
A076665-002	AB
A076665-003	AB
A076665-004	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	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-004	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	A076665-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076665-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076665-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076665-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076665-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076665-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076665-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-004	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	150 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197699	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
8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUCONAZOLE	FLUCONAZOLE	HAWAII REPACK, INC.	8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076665 application number: ANDA076665 ndc (product): 85534-0049
FLUCONAZOLE	FLUCONAZOLE	Chartwell RX, LLC	f86ea347-78f5-43b8-9574-a52569a4237b	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076665 application number: ANDA076665
FLUCONAZOLE	FLUCONAZOLE	Asclemed USA, Inc.	3208dc64-6117-4b2d-9008-76a819cef7d7	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076665 application number: ANDA076665

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	Sample	Exclude flag	Status
85534-0049-0	85534004900	1 TABLET in 1 BOTTLE (85534-0049-0)	1 tablet	2026-07-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUCONAZOLE TABLETS, USP 150 mg Rx Only	HAWAII REPACK, INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-07-03	HUMAN PRESCRIPTION DRUG LABEL	1