Application 077909

Type: ANDA
Sponsor: WOODWARD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	No	No
002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	No	No
003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	100MG/50ML (2MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26
A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26
A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077909-001	AP
A077909-002	AP

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 4 · 129 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	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077909-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077909-003	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	100MG/50ML (2MG/ML)	INJECTABLE / INJECTION		2015-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077909-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A077909-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077909-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077909-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077909-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077909-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077909-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077909-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077909-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077909-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077909-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077909-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077909-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077909-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077909-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077909-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077909-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077909-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077909-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077909-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077909-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077909-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077909-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077909-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077909-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077909-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077909-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077909-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077909-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077909-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077909-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077909-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077909-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077909-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077909-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077909-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077909-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077909-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077909-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077909-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077909-002	AP	1	`74a2ff9319b5…`

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 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	aaf9e5f8-048e-407c-bc11-ad4edff85c05	2026-09-10	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	1c82929f-934b-4df4-b24f-1e5da090fd8a	2026-09-04	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	2bd1c038-ab82-496c-8129-3182238ad1a1	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	16b6fba0-b96f-4252-a70d-31dc61400298	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	485f0414-036f-4f42-87ee-a89543ac94c1	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	A-S Medication Solutions	7961c029-746c-48c3-888b-8f8344102873	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	St. Mary's Medical Park Pharmacy	c89c3bbd-1170-4170-e053-2a95a90a8e41	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Redpharm Drug	568d9f2f-3394-b972-e063-6394a90a8628	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	6bb386b0-9dbe-40ee-b873-5215b1905920	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
FLUCONAZOLE	FLUCONAZOLE	HAWAII REPACK, INC.	8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8	2026-07-03	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	St. Mary's Medical Park Pharmacy	126406ae-1fdc-df20-e063-6294a90a2718	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	67af604c-928f-468b-ba27-ad45e95d3e7e	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	7259671f-a703-4a2a-81db-9a4839b34072	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a995790a-8470-4c51-801a-69347151a6fe	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	0de7211d-b8ce-214d-e063-6294a90aec41	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	726daf35-4c03-464f-a814-cc0a715d6031	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	dd975843-c3e4-44f4-bb0d-33b294c1f6fb	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	91adb548-9875-47e9-8054-578ed8c7572e	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	ASCLEMED USA INC.	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69784-261	Fluconazole in Sodium Chloride	Fluconazole, Sodium Chloride	Woodward Pharma Services LLC	ANDA	Current
69784-261	Fluconazole in Sodium Chloride	Fluconazole, Sodium Chloride	Woodward Pharma Services LLC	ANDA	Current