FDA.reportPublic FDA data

FOSCARNET SODIUM

Product NDC
43066-089
11-digit product format
430660089
Labeler code
43066
Product ID
43066-089_f3b7e70d-5ed4-4d9a-a11b-84c3c4deb607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
foscarnet sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA213001
Marketing category
ANDA
Marketing start
2023-08-28
Substance
FOSCARNET SODIUM
Active strength
6000 mg/250mL
Pharmacologic classes
Chelating Activity [MoA], DNA Polymerase Inhibitors [MoA], Pyrophosphate Analog DNA Polymerase Inhibitor [EPC], Pyrophosphate Analog [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FOSCARNET SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSCARNET SODIUM6000 mg/250mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii964YS0OOG1
Rxcui1734377

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73131091-13a4-6812-4f73-a5ec655c7fe9Product name320240606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43066-089-10FOSCARNET SODIUM250 mL in 1 BAGINJECTION, SOLUTION2505
43066-089-10FOSCARNET SODIUM10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-089-10ML - Milliliter43066-089de7b4163-a801-4c0f-b1b0-f5714a4ca96712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-089FOSCARNET SODIUM INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4Current NDC, 2 package rows20250223_8a7caffd-9d8a-4d45-ad48-70d511a89c29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSN8a7caffd-9d8a-4d45-ad48-70d511a89c295
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCD8a7caffd-9d8a-4d45-ad48-70d511a89c295
1734377foscarnet sodium 6000 MG per 250 ML InjectionSY8a7caffd-9d8a-4d45-ad48-70d511a89c295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43066-089-104306600891010 BAG in 1 CARTON (43066-089-10) / 250 mL in 1 BAG10 bag2023-08-28NoNoHistorical