Fluconazole

Product NDC: 76420-164
Requested package NDC: 76420-164-01
11-digit product format: 764200164
Labeler code: 76420
Product ID: 76420-164_d964ddff-cfca-92ad-e053-2995a90a6568
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA077253
Marketing category: ANDA
Marketing start: 2020-11-20
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077253-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25
A077253-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25
A077253-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25
A077253-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077253-001	AB
A077253-002	AB
A077253-003	AB
A077253-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077253-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2006-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077253-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2006-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077253-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2006-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077253-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2006-01-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077253-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077253-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077253-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077253-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077253-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077253-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077253-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077253-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077253-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077253-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077253-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077253-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077253-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluconazole
Listing expiration: 2026-12-31

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
56a9de97-bbb9-4210-9ace-f77317d5f33b	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
76420-164-01	Fluconazole	1 in 1 BLISTER PACK	TABLET	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-164-01	EA - Each	76420-164	f361f605-d0cf-4163-8423-d00bcacd0d62	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-164	FLUCONAZOLE TABLET [ASCLEMED USA, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20220305_56a9de97-bbb9-4210-9ace-f77317d5f33b.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 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	St. Mary's Medical Park Pharmacy	c89c3bbd-1170-4170-e053-2a95a90a8e41	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	0de7211d-b8ce-214d-e063-6294a90aec41	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	dd975843-c3e4-44f4-bb0d-33b294c1f6fb	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	e222031d-58f6-46d6-99f8-320b9aacf2b2	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Coupler LLC	519e44f4-9318-572e-e063-6394a90afe93	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f5	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Glenmark Pharmaceuticals Inc., USA	3da5f41d-5200-45ac-b89d-00881237ec85	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	f76bf2f7-1752-7656-e053-6394a90a8d22	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	BluePoint Laboratories	83bcb8fc-53f1-4d7b-b083-0905b52c6c7e	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Radha Pharmaceuticals Inc	4616c7ad-be61-7ac0-e063-6394a90ab9ed	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	aaf9e5f8-048e-407c-bc11-ad4edff85c05	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Coupler LLC	325d5d69-5132-79ea-e063-6294a90afdd0	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Proficient Rx LP	c0193e27-f1a4-4698-a6bb-3df772c16256	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	cf6c7cca-d074-2178-e053-2a95a90a3af7	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
FLUCONAZOLE	FLUCONAZOLE	Direct Rx	db886cfe-ea23-50c9-e053-2995a90a4d10	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	2fcac0e4-4f12-42d2-b129-106b4e100075	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fbb1bda3-f733-4404-9c9d-46c418700c03	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253
Fluconazole	FLUCONAZOLE	Asclemed USA, Inc.	56a9de97-bbb9-4210-9ace-f77317d5f33b	2022-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077253 application number: ANDA077253 ndc (package): 76420-164-01 ndc (product): 76420-164 ndc11 (package): 76420016401

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
197699	fluconazole 150 MG Oral Tablet	PSN	56a9de97-bbb9-4210-9ace-f77317d5f33b	1
197699	fluconazole 150 MG Oral Tablet	SCD	56a9de97-bbb9-4210-9ace-f77317d5f33b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-164-01	76420016401	1 TABLET in 1 BLISTER PACK (76420-164-01)	1 tablet	2022-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-03-04	HUMAN PRESCRIPTION DRUG LABEL	1