FDA.reportPublic FDA data

Foscarnet Sodium

Product NDC
70121-1744
11-digit product format
701211744
Labeler code
70121
Product ID
70121-1744_1b830de7-7f0a-4c5a-81ae-ddd0d3f1f128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Foscarnet Sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA216602
Marketing category
ANDA
Marketing start
2024-03-04
Substance
FOSCARNET SODIUM
Active strength
24 mg/mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Foscarnet Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSCARNET SODIUM24 mg/mL

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
70121-1744-2Foscarnet Sodium12 in 1 CARTONINJECTION128
70121-1744-2Foscarnet Sodium1 in 1 POUCHINJECTION18
70121-1744-7Foscarnet Sodium10 in 1 CARTONINJECTION108
70121-1744-7Foscarnet Sodium1 in 1 POUCHINJECTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1744-2ML - Milliliter70121-1744ab58d83a-8aa8-4067-969c-7aa705a246de12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1744FOSCARNET SODIUM INJECTION [AMNEAL PHARMACEUTICALS LLC]8Current NDC, 4 package rows20241113_b03cbb8e-f555-4ed3-854e-dd962604f144.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSNb03cbb8e-f555-4ed3-854e-dd962604f1448
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCDb03cbb8e-f555-4ed3-854e-dd962604f1448
1734377foscarnet sodium 6000 MG per 250 ML InjectionSYb03cbb8e-f555-4ed3-854e-dd962604f1448

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1744-27012117440212 POUCH in 1 CARTON (70121-1744-2) / 1 BAG in 1 POUCH / 250 mL in 1 BAG12 pouch2024-03-04NoNoHistorical
70121-1744-77012117440710 POUCH in 1 CARTON (70121-1744-7) / 1 BAG in 1 POUCH / 250 mL in 1 BAG10 pouch2024-03-04NoNoHistorical