Fluconazole

Product NDC: 53002-1198
Requested package NDC: 53002-1198-2
11-digit product format: 530021198
Labeler code: 53002
Product ID: 53002-1198_c1e1a93a-ff95-44c5-bf21-d5c16b6bd90f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA078423
Marketing category: ANDA
Marketing start: 2017-02-24
Marketing end: 0000-00-00
Substance: FLUCONAZOLE
Active strength: 150 mg/1
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1198	53002-1198-2	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

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
A078423-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07
A078423-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07
A078423-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07
A078423-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078423-001	AB
A078423-002	AB
A078423-003	AB
A078423-004	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	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`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	A078423-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078423-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078423-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078423-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078423-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078423-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078423-004	AB	1	`d06236e962d9…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-1198-1	2023-01-30	Fluconazole Tablets, USP
53002-1198-2	2023-01-30	Fluconazole Tablets, USP
53002-1198-1	2021-06-17	Fluconazole Tablets, USP
53002-1198-2	2021-06-17	Fluconazole Tablets, USP
53002-1198-1	2020-01-31	Fluconazole Tablets, USP
53002-1198-2	2020-01-31	Fluconazole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-1198-1	Fluconazole	1 in 1 BLISTER PACK	TABLET	1		5
53002-1198-2	Fluconazole	2 in 1 BLISTER PACK	TABLET	2		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1198	FLUCONAZOLE TABLET [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20210617_b00ead0c-c3fc-43a0-bc85-86c6c155635e.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	91adb548-9875-47e9-8054-578ed8c7572e	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Golden State Medical Supply, Inc.	c2c7242d-d172-4733-e053-2995a90acb2e	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	2c9abaee-461f-437d-adda-e96d7ae3dd01	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a0f1c111-e11e-4b7e-b990-8bc271cbc940	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	701cd91f-4f79-48a7-8fe5-a9678d7a4ac8	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	ANI Pharmaceuticals, Inc.	8f90f169-6a72-4c33-a2af-0bc943602bc2	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	d9e772e9-d916-42ae-8020-89b263236102	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	c94b8ecf-249f-42d6-a030-4cfb83fddb08	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	877aea10-b019-4eeb-8a1e-e6ac583df966	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	b94ca865-ab2f-466c-9913-dde9376e4533	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	6b2bc10f-21a8-422a-9ea3-ed7788ffce6b	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Proficient Rx LP	b0aa9b22-5aef-459f-bb11-b193343eeb86	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423

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	b00ead0c-c3fc-43a0-bc85-86c6c155635e	5
197699	fluconazole 150 MG Oral Tablet	PSN	b00ead0c-c3fc-43a0-bc85-86c6c155635e	5
197698	fluconazole 100 MG Oral Tablet	SCD	b00ead0c-c3fc-43a0-bc85-86c6c155635e	5
197699	fluconazole 150 MG Oral Tablet	SCD	b00ead0c-c3fc-43a0-bc85-86c6c155635e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1198-2	53002119802	2 TABLET in 1 BLISTER PACK (53002-1198-2)	2 tablet	2017-09-01	0000-00-00	No	No	Current