Foscarnet Sodium

Product NDC
0143-9192
11-digit product format
001439192
Labeler code
0143
Product ID
0143-9192_148361f3-4366-9f0f-e063-6394a90a69e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
foscarnet sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA213987
Marketing category
ANDA
Marketing start
2023-11-29
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

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213987-001FOSCARNET SODIUMFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213987-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213987-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-11-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213987-001AP1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foscarnet SodiumFOSCARNET SODIUMHikma Pharmaceuticals USA Inc.b612e6f1-584f-4188-b96e-1a9adfcfe75c2024-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213987
application number: ANDA213987
ndc (product): 0143-9192

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
964YS0OOG1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734377Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b612e6f1-584f-4188-b96e-1a9adfcfe75cAvailable on FDA.report

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
0143-9192-01Foscarnet Sodium10 in 1 CASEINJECTION, SOLUTION102
0143-9192-01Foscarnet Sodium1 in 1 CARTONINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9192-01ML - Milliliter0143-9192bcfb6b74-35bb-43b2-a01b-a42b1893bf6912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9192FOSCARNET SODIUM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, 2 package rows20240404_b612e6f1-584f-4188-b96e-1a9adfcfe75c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSNb612e6f1-584f-4188-b96e-1a9adfcfe75c2
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCDb612e6f1-584f-4188-b96e-1a9adfcfe75c2
1734377foscarnet sodium 6000 MG per 250 ML InjectionSYb612e6f1-584f-4188-b96e-1a9adfcfe75c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9192-010014391920110 CARTON in 1 CASE (0143-9192-01) / 1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE10 carton2023-11-29NoNoCurrent