Fluconazole

Product NDC: 70985-014
11-digit product format: 709850014
Labeler code: 70985
Product ID: 70985-014_eb51cf40-8e0c-3478-e053-2995a90ac6e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Drug Ocean LLC
Application: ANDA076957
Marketing category: ANDA
Marketing start: 2021-06-26
Marketing end: 0000-00-00
Substance: FLUCONAZOLE
Active strength: 100 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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70985-014		D	Discontinued by firm	2026-10-05
excluded package	package	70985-014	70985-014-01	D	Discontinued by firm	2026-10-05
excluded package	package	70985-014	70985-014-03	D	Discontinued by firm	2026-10-05

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70985-014		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70985-014	70985-014-03	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70985-014	70985-014-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A076957-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28
A076957-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28
A076957-003	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28
A076957-004	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076957-001	AB
A076957-002	AB
A076957-003	AB
A076957-004	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	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2005-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2005-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-003	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2005-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076957-004	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076957-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076957-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076957-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076957-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076957-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076957-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076957-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076957-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076957-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076957-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076957-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076957-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076957-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076957-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076957-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076957-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076957-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076957-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076957-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076957-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076957-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076957-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076957-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076957-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076957-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076957-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076957-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076957-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076957-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076957-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076957-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076957-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076957-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076957-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076957-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076957-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076957-004	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70985-014	FLUCONAZOLE TABLET [DRUG OCEAN LLC]	14	Legacy NDC	20241118_c5bfc182-b35f-afc4-e053-2a95a90ae5c3.zip

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	Marketing end	Sample	Exclude flag	Status
70985-014-01	70985001401	100 TABLET in 1 BOTTLE (70985-014-01)	100 tablet	2021-06-26	0000-00-00	No	No	Current
70985-014-03	70985001403	30 TABLET in 1 BOTTLE (70985-014-03)	30 tablet	2021-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets USP	Drug Ocean LLC \| Unique Pharmaceutical Laboratories	2024-11-15	HUMAN PRESCRIPTION DRUG LABEL	14