FDA.reportPublic FDA data

foscarnet sodium

Product NDC
23155-771
11-digit product format
231550771
Labeler code
23155
Product ID
23155-771_7de2fbfd-a1c3-4320-8212-bfeeff0a20a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
foscarnet sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA213807
Marketing category
ANDA
Marketing start
2023-06-05
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage23155-77123155-771-41DDiscontinued by firm2026-07-31

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
A213807-001FOSCARNET SODIUMFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213807-001AP

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 22:54:322026-06A213807-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-06-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213807-001AP1a50c72e98297…

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 SODIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d2b4ce68-5a81-4b14-8914-21bc38f010082025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213807
application number: ANDA213807
ndc (product): 23155-771

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
d2b4ce68-5a81-4b14-8914-21bc38f01008Available 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
23155-771-31foscarnet sodium250 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION2504
23155-771-31foscarnet sodium1 in 1 CARTONINJECTION, SOLUTION14
23155-771-41foscarnet sodium10 in 1 CARTONINJECTION, SOLUTION104
23155-771-41foscarnet sodium250 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION2504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-771-31ML - Milliliter23155-7718f2da777-999c-4195-bd5a-e6c235feb38912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-771FOSCARNET SODIUM INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, 4 package rows20250330_d2b4ce68-5a81-4b14-8914-21bc38f01008.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSNd2b4ce68-5a81-4b14-8914-21bc38f010084
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCDd2b4ce68-5a81-4b14-8914-21bc38f010084
1734377foscarnet sodium 6000 MG per 250 ML InjectionSYd2b4ce68-5a81-4b14-8914-21bc38f010084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-771-31231550771311 BOTTLE, GLASS in 1 CARTON (23155-771-31) / 250 mL in 1 BOTTLE, GLASS2023-06-05NoNoCurrent
23155-771-412315507714110 in 1 CARTONHistorical