Fluconazole

Product NDC: 0143-9666
11-digit product format: 001439666
Labeler code: 0143
Product ID: 0143-9666_a90257a3-d842-4990-81a5-614293e23119
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA078764
Marketing category: ANDA
Marketing start: 2012-01-30
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION			2012-01-30
A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION			2012-01-30

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078764-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078764-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2012-01-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078764-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078764-002	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078764-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078764-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078764-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078764-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078764-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078764-002	AP	1	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUCONAZOLE	2 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1721314	Internal RxNorm lookup
1721315	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
d3ca59bd-ae00-48ab-89aa-87c7f56e9989	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
0143-9666-01	Fluconazole	200 mL in 1 CONTAINER	INJECTION	200		19
0143-9666-06	Fluconazole	6 in 1 CARTON	INJECTION	6		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9666-01	ML - Milliliter	0143-9666	a590c705-1e13-491a-884a-c2652e8b990b	1	2013-05-02
0143-9666-06	ML - Milliliter	0143-9666	e3e5da98-5f04-4f73-9298-9d8548bb44cc	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	9
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	9
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	9
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUCONAZOLE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9666	FLUCONAZOLE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	19	Current NDC, Legacy NDC, 2 package rows	20240629_d3ca59bd-ae00-48ab-89aa-87c7f56e9989.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Hikma Pharmaceuticals USA Inc.	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078764 application number: ANDA078764 ndc (product): 0143-9666

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
1721315	fluconazole 200 MG in 100 ML Injection	PSN	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	19
1721314	fluconazole 400 MG in 200 ML Injection	PSN	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	19
1721315	100 ML fluconazole 2 MG/ML Injection	SCD	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	19
1721314	200 ML fluconazole 2 MG/ML Injection	SCD	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	19
1721315	fluconazole 200 MG per 100 ML Injection	SY	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	19
1721314	fluconazole 400 MG per 200 ML Injection	SY	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9666-01	00143966601	200 mL in 1 CONTAINER	200 ml					Historical
0143-9666-06	00143966606	6 CONTAINER in 1 CARTON (0143-9666-06) / 200 mL in 1 CONTAINER (0143-9666-01)	6 container	2012-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUCONAZOLE INJECTION, USP	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2024-06-28	HUMAN PRESCRIPTION DRUG LABEL	19