Fluconazole

Product NDC: 25021-113
Requested package NDC: 25021-113-82
11-digit product format: 250210113
Labeler code: 25021
Product ID: 25021-113_970858ed-806f-4143-919a-27341227bd8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA079104
Marketing category: ANDA
Marketing start: 2009-09-01
Marketing end: 2021-05-31
Substance: FLUCONAZOLE
Active strength: 2 mg/mL
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	25021-113	25021-113-82	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A079104-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-07-30
A079104-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079104-001	AP
A079104-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A079104-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-07-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079104-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-07-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A079104-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A079104-002	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Hospira, Inc	22ebc3fb-ee81-44bd-a6e3-5e759ee724a8	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079104 application number: ANDA079104
Fluconazole	FLUCONAZOLE	Sagent Pharmaceuticals	02f74fe7-0649-46c5-a06a-0700cd265773	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079104 application number: ANDA079104
Fluconazole	FLUCONAZOLE	Sagent Pharmaceuticals	c041227b-dab6-4c29-ab59-d31993d524b2	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079104 application number: ANDA079104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-113-82	ML - Milliliter	25021-113	06f3cfad-a704-42e4-8af4-5ea59b7eed70	1	2012-07-24
25021-113-87	ML - Milliliter	25021-113	dc48c781-5f44-4c41-b17d-c4a9c3ef9c9c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluconazole	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	12
Fluconazole	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	12
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	12
water	INACTIVE INGREDIENT	059QF0KO0R	FLUCONAZOLE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	12

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
25021-113-82	25021011382	10 POUCH in 1 CARTON (25021-113-82) > 1 BAG in 1 POUCH > 100 mL in 1 BAG	10 pouch	2009-09-01	2021-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUCONAZOLE INJECTION, USP (in 0.9% Sodium Chloride) For Intravenous Infusion only	Sagent Pharmaceuticals	2017-01-20	HUMAN PRESCRIPTION DRUG LABEL	15