Fluconazole in Sodium Chloride

Product NDC: 69784-261
Requested package NDC: 69784-261-24
11-digit product format: 697840261
Labeler code: 69784
Product ID: 69784-261_957fcf46-6682-44d5-ad7f-5ce3c51bef52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole, Sodium Chloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Woodward Pharma Services LLC
Application: ANDA077909
Marketing category: ANDA
Marketing start: 2020-10-01
Marketing end: 0000-00-00
Substance: FLUCONAZOLE
Active strength: 2 mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69784-261	69784-261-24	D	Discontinued by firm		2026-09-14

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-09-15	05f5daec-e066-483f-9aec-0230c4f1a6bf
2025-01-30	05f5daec-e066-483f-9aec-0230c4f1a6bf
2022-07-30	05f5daec-e066-483f-9aec-0230c4f1a6bf
2022-01-28	05f5daec-e066-483f-9aec-0230c4f1a6bf

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69784-261-24	ML - Milliliter	69784-261	4aa044d8-4e8c-4103-96ba-f0901acbd8a4	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69784-261	FLUCONAZOLE IN SODIUM CHLORIDE (FLUCONAZOLE, SODIUM CHLORIDE) INJECTION [WOODWARD PHARMA SERVICES LLC]	2	Legacy NDC	20220731_05f5daec-e066-483f-9aec-0230c4f1a6bf.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
69784-261-24	69784026124	50 mL in 1 CONTAINER (69784-261-24)	50 ml	2020-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole in Sodium Chloride - Woodward Pharma Services LLC	Woodward Pharma Services LLC	2022-07-29	HUMAN PRESCRIPTION DRUG LABEL	2