FDA.reportPublic FDA data

Foscarnet Sodium

Product NDC
65145-191
11-digit product format
651450191
Labeler code
65145
Product ID
65145-191_6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Foscarnet Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA220068
Marketing category
ANDA
Marketing start
2026-05-20
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A220068-001FOSCARNET SODIUMFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2026-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220068-001AP

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
2026-08-18 06:07:402026-07A220068-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2026-05-13caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220068-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2026-05-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220068-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220068-001AP1a50c72e98297…

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
6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a95Available 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
65145-191-01Foscarnet Sodium250 mL in 1 BAGINJECTION, SOLUTION2501
65145-191-01Foscarnet Sodium1 in 1 POUCHINJECTION, SOLUTION11
65145-191-10Foscarnet Sodium10 in 1 CASEINJECTION, SOLUTION101

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foscarnet SodiumFOSCARNET SODIUMCaplin Steriles Limited6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a952026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220068
application number: ANDA220068
ndc (product): 65145-191

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSN6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a951
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCD6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a951
1734377foscarnet sodium 6000 MG per 250 ML InjectionSY6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-191-0165145019101250 mL in 1 BAG250 mlHistorical
65145-191-106514501911010 POUCH in 1 CASE (65145-191-10) / 1 BAG in 1 POUCH (65145-191-01) / 250 mL in 1 BAG10 pouch2026-05-20NoNoCurrent