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

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
A216602-001FOSCARNET SODIUMFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2024-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216602-001AP

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 22:54:322026-06A216602-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2024-03-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216602-001AP1a50c72e98297…

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 SODIUMAmneal Pharmaceuticals LLCb03cbb8e-f555-4ed3-854e-dd962604f1442026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216602
application number: ANDA216602
ndc (product): 70121-1744

Additional Listing Data#

Finished product
Yes
Brand name base
Foscarnet Sodium
Listing expiration
2027-12-31

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
b03cbb8e-f555-4ed3-854e-dd962604f144Available 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
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 pouch2024-03-04NoNoCurrent
70121-1744-77012117440710 POUCH in 1 CARTON (70121-1744-7) / 1 BAG in 1 POUCH / 250 mL in 1 BAG10 pouch2024-03-04NoNoCurrent