FDA.reportPublic FDA data

Foscarnet Sodium

Product NDC
25021-189
11-digit product format
250210189
Labeler code
25021
Product ID
25021-189_f5829ec8-15e6-43a4-a5f0-68ea0cddb8c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Foscarnet Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA213001
Marketing category
ANDA
Marketing start
2021-05-15
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
A213001-001FOSCARNET SODIUMFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2021-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213001-001AP

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 22:54:322026-06A213001-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2021-04-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213001-001AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOSCARNET SODIUMFOSCARNET SODIUMBaxter Healthcare Corporation8a7caffd-9d8a-4d45-ad48-70d511a89c292023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213001
application number: ANDA213001
Foscarnet SodiumFOSCARNET SODIUMGland Pharma Limitedd4048736-389f-48d8-aadd-6bc76d604ddb2021-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213001
application number: ANDA213001
Foscarnet SodiumFOSCARNET SODIUMSagent Pharmaceuticals2f49c1bc-0828-4e5c-a3c0-81e997213b0e2021-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213001
application number: ANDA213001
ndc (product): 25021-189

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
2f49c1bc-0828-4e5c-a3c0-81e997213b0eAvailable 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
25021-189-84Foscarnet Sodium10 in 1 CARTONINJECTION, SOLUTION101
25021-189-84Foscarnet Sodium250 mL in 1 BAGINJECTION, SOLUTION2501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-189-84ML - Milliliter25021-189647e350b-a245-4b73-af9b-e561000d6a8d12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-189FOSCARNET SODIUM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, Legacy NDC, 2 package rows20210515_2f49c1bc-0828-4e5c-a3c0-81e997213b0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSN2f49c1bc-0828-4e5c-a3c0-81e997213b0e1
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCD2f49c1bc-0828-4e5c-a3c0-81e997213b0e1
1734377foscarnet sodium 6000 MG per 250 ML InjectionSY2f49c1bc-0828-4e5c-a3c0-81e997213b0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-189-842502101898410 BAG in 1 CARTON (25021-189-84) / 250 mL in 1 BAG10 bag2021-05-150000-00-00NoNoCurrent