Fluconazole

Product NDC: 0338-6045
11-digit product format: 003386045
Labeler code: 0338
Product ID: 0338-6045_36e35cdf-c4a0-428a-879e-1d65e2b66f64
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: ANDA076766
Marketing category: ANDA
Marketing start: 2004-07-29
Substance: FLUCONAZOLE
Active strength: 400 mg/200mL
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: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
FLUCONAZOLE	400 mg/200mL

Field, Values table
Field	Values
Unii	8VZV102JFY
Rxcui	1721314, 1721315

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-6045-37	Fluconazole	10 in 1 CARTON	INJECTION, SOLUTION	10		27
0338-6045-37	Fluconazole	200 mL in 1 BAG	INJECTION, SOLUTION	200		27

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-6045-37	ML - Milliliter	0338-6045	87148652-a4d1-48e4-8a7b-1fb74056e601	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	6
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	6

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-6045	FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	26	Current NDC, Legacy NDC, 2 package rows	20250507_cd24a261-9c15-42b4-8040-89d2dbda174e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8VZV102JFY	FLUCONAZOLE	86386-73-4	FLUCONAZOLE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1721315	fluconazole 200 MG in 100 ML Injection	PSN	cd24a261-9c15-42b4-8040-89d2dbda174e	27
1721314	fluconazole 400 MG in 200 ML Injection	PSN	cd24a261-9c15-42b4-8040-89d2dbda174e	27
1721315	100 ML fluconazole 2 MG/ML Injection	SCD	cd24a261-9c15-42b4-8040-89d2dbda174e	27
1721314	200 ML fluconazole 2 MG/ML Injection	SCD	cd24a261-9c15-42b4-8040-89d2dbda174e	27
1721315	fluconazole 200 MG per 100 ML Injection	SY	cd24a261-9c15-42b4-8040-89d2dbda174e	27
1721314	fluconazole 400 MG per 200 ML Injection	SY	cd24a261-9c15-42b4-8040-89d2dbda174e	27

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-6045-37	00338604537	10 BAG in 1 CARTON (0338-6045-37) / 200 mL in 1 BAG	10 bag	2004-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole in Sodium Chloride Injection, USP For intravenous infusion only in Intravia Plastic Container	Baxter Healthcare Company \| Baxter Healthcare Corporation	2024-06-24	HUMAN PRESCRIPTION DRUG LABEL	27