Fluconazole in Sodium Chloride

Product NDC
0409-4688
11-digit product format
004094688
Labeler code
0409
Product ID
0409-4688_7d067fc8-7c07-4eb2-ab3e-2f99c6015875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole in Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA076303
Marketing category
ANDA
Marketing start
2006-04-17
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4688-02ML - Milliliter0409-468810717df1-c4eb-4ebc-bea5-29b3f5de061612012-07-24
0409-4688-06ML - Milliliter0409-468889a7fe30-2b7b-497f-b111-755237e2148012015-04-03
0409-4688-12ML - Milliliter0409-46885b20010a-54f5-4c60-b517-365cb8c6ce0b12016-01-13
0409-4688-16ML - Milliliter0409-468804c52288-9153-41c9-bc81-ed5c1fe9c93412016-12-07
0409-4688-18ML - Milliliter0409-468883834969-95f0-4b6b-b30a-c58a103ac12712016-03-04
0409-4688-22ML - Milliliter0409-468878111fd8-dcfb-4104-8c4d-4047570be06b12016-03-04
0409-4688-23ML - Milliliter0409-4688cf9de219-60b2-4f92-a865-240c82e3abdc12012-07-24
0409-4688-27ML - Milliliter0409-46880438ccfe-3efb-4add-9a95-dba3abd3bc5812012-07-24
0409-4688-28ML - Milliliter0409-4688d3a1f7eb-a05c-485b-8906-e9c582e663f212012-07-24
0409-4688-29ML - Milliliter0409-468848f11a93-137f-4271-bf7a-0b43111dc33712015-04-03
0409-4688-33ML - Milliliter0409-46883fe72f0c-ff1b-4965-beb2-d69762944d2012012-07-24
0409-4688-34ML - Milliliter0409-46886005132b-c218-4a87-b77f-81f0f623db3712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.]12
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.]12
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GFLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4688FLUCONAZOLE IN SODIUM CHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]29Legacy NDC20240627_b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4688-120040946881224 BAG in 1 CASE (0409-4688-12) > 200 mL in 1 BAG (0409-4688-16) 24 bag2015-10-210000-00-00NoNoCurrent
0409-4688-180040946881824 BAG in 1 CASE (0409-4688-18) > 100 mL in 1 BAG (0409-4688-22) 24 bag2015-12-180000-00-00NoNoCurrent