Foscarnet Sodium

Product NDC
68083-389
11-digit product format
680830389
Labeler code
68083
Product ID
68083-389_e7d4415b-96cc-4f7b-b639-7369baf4871a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Foscarnet Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA213001
Marketing category
ANDA
Marketing start
2021-04-21
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
68083-389-01Foscarnet Sodium1 in 1 CARTONINJECTION, SOLUTION15
68083-389-01Foscarnet Sodium250 mL in 1 BAGINJECTION, SOLUTION2505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-389FOSCARNET SODIUM INJECTION, SOLUTION [GLAND PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20210425_d4048736-389f-48d8-aadd-6bc76d604ddb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSNd4048736-389f-48d8-aadd-6bc76d604ddb5
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCDd4048736-389f-48d8-aadd-6bc76d604ddb5
1734377foscarnet sodium 6000 MG per 250 ML InjectionSYd4048736-389f-48d8-aadd-6bc76d604ddb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-389-01680830389011 BAG in 1 CARTON (68083-389-01) / 250 mL in 1 BAG1 bag2021-04-210000-00-00NoNoCurrent