Fluconazole

Product NDC: 70518-4020
Requested package NDC: 70518-4020-1
11-digit product format: 705184020
Labeler code: 70518
Product ID: 70518-4020_5410bb53-b81b-16dd-e063-6394a90a564e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077731
Marketing category: ANDA
Marketing start: 2024-02-12
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: 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
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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197700	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
726daf35-4c03-464f-a814-cc0a715d6031	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
70518-4020-0	Fluconazole	30 in 1 BLISTER PACK	TABLET	30		5
70518-4020-1	Fluconazole	2 in 1 BOTTLE, PLASTIC	TABLET	2		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4020	FLUCONAZOLE TABLET [REMEDYREPACK INC.]	3	Current NDC, 2 package rows	20241207_726daf35-4c03-464f-a814-cc0a715d6031.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 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	1c82929f-934b-4df4-b24f-1e5da090fd8a	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	2bd1c038-ab82-496c-8129-3182238ad1a1	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	485f0414-036f-4f42-87ee-a89543ac94c1	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Redpharm Drug	568d9f2f-3394-b972-e063-6394a90a8628	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	6bb386b0-9dbe-40ee-b873-5215b1905920	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	St. Mary's Medical Park Pharmacy	126406ae-1fdc-df20-e063-6294a90a2718	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a995790a-8470-4c51-801a-69347151a6fe	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	726daf35-4c03-464f-a814-cc0a715d6031	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731 ndc (package): 70518-4020-1 ndc (product): 70518-4020 ndc11 (package): 70518402001
Fluconazole	FLUCONAZOLE	ASCLEMED USA INC.	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	eeeb82e1-d668-418e-9716-f8bcf72f80c0	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	5cbd78cd-2cd7-4882-9902-bdb7812fbc6b	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	f25f31a6-4bad-40fa-bced-695552e27afd	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Sportpharm LLC	60f3e8af-d98f-48dd-83e6-a78315aaed22	2026-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Sportpharm LLC	98ac5455-d26c-4780-a5a3-bf8d85917626	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	AvPAK	551a5c8f-57eb-2643-12c6-7c700584b49f	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	c924c51c-ed7e-7e72-e053-2995a90adcd3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	124c1ffa-08fd-eca5-e063-6294a90af0e2	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	c6be26bb-af92-405b-9908-972d6e985cf0	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	01df20c4-7b94-044e-e063-6394a90a406a	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077731 application number: ANDA077731
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	28d53f27-a0cd-4d8d-e054-00144ff8d46c	2025-10-15	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	726daf35-4c03-464f-a814-cc0a715d6031	5
197700	fluconazole 200 MG Oral Tablet	SCD	726daf35-4c03-464f-a814-cc0a715d6031	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4020-1	70518402001	2 TABLET in 1 BOTTLE, PLASTIC (70518-4020-1)	2 tablet	2025-10-12	No	No	Current