FDA.reportPublic FDA data

Foscavir

Product NDC
76310-024
Requested package NDC
76310-024-45
11-digit product format
763100024
Labeler code
76310
Product ID
76310-024_6792504c-7fa0-4179-9c76-1f6a2ced2832
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
foscarnet sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Clinigen Limited
Application
NDA020068
Marketing category
NDA
Marketing start
2012-07-09
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 packagepackage76310-02476310-024-45DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020068-001FOSCAVIRFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS1991-09-27
N020068-002FOSCAVIRFOSCARNET SODIUM12GM/500ML (24MG/ML)SOLUTION / INTRAVENOUSRLD1991-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020068-001AP

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 22:54:322026-06N020068-001FOSCAVIR6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS1991-09-27a50c72e98297…
2026-08-01 22:54:322026-06N020068-002FOSCAVIR12GM/500ML (24MG/ML)SOLUTION / INTRAVENOUSRLD1991-09-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020068-001AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FoscavirFOSCARNET SODIUMClinigen Limiteda09299d5-9c55-4cef-aed0-3a6a455322892025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020068
application number: NDA020068
ndc (product): 76310-024
FoscavirFOSCARNET SODIUMClinigen Limited90e3da4e-3b1f-428b-99ca-e4bed1c800282025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020068
application number: NDA020068
ndc (product): 76310-024

Additional Listing Data#

Finished product
Yes
Brand name base
Foscavir
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855613Internal RxNorm lookup
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
a09299d5-9c55-4cef-aed0-3a6a45532289Available 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
76310-024-15Foscavir1 in 1 CARTONINJECTION, SOLUTION122
76310-024-15Foscavir250 mL in 1 BOTTLEINJECTION, SOLUTION25022
76310-024-25Foscavir10 in 1 CARTONINJECTION, SOLUTION1022
76310-024-01Foscavir10 in 1 CARTONINJECTION, SOLUTION1016
76310-024-11Foscavir1 in 1 CARTONINJECTION, SOLUTION116
76310-024-11Foscavir250 mL in 1 BOTTLEINJECTION, SOLUTION25016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76310-024-01ML - Milliliter76310-024d42ef6be-3360-41b4-979d-2ed71db2449312015-03-03
76310-024-11ML - Milliliter76310-024e864fc20-812d-4db6-bf3d-ae61ddc1443412019-05-02
76310-024-15ML - Milliliter76310-024c6522f73-3765-465b-8ae0-02b16a63fe2c12018-08-13
76310-024-25ML - Milliliter76310-02497ab2e67-b14b-45cf-9c0f-a1eb895f75aa12013-02-13
76310-024-41ML - Milliliter76310-02476dcf366-1dee-4a3b-8b56-8b106690bb4212021-05-05
76310-024-45ML - Milliliter76310-024f43f7d6d-fa25-4dec-ab95-c3467b5d459012021-04-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
foscarnet sodiumACTIVE INGREDIENT964YS0OOG1FOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]8
foscarnetACTIVE MOIETY364P9RVW4XFOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]8
hydrochloric acidINACTIVE INGREDIENTQTT17582CBFOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]8
waterINACTIVE INGREDIENT059QF0KO0RFOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]8
foscarnet sodiumACTIVE INGREDIENT964YS0OOG1FOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]2
foscarnetACTIVE MOIETY364P9RVW4XFOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBFOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]2
waterINACTIVE INGREDIENT059QF0KO0RFOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN HEALTHCARE LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76310-024FOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN LIMITED]21Current NDC, Legacy NDC, 3 package rows20241122_a09299d5-9c55-4cef-aed0-3a6a45532289.zip
76310-024FOSCAVIR (FOSCARNET SODIUM) INJECTION, SOLUTION [CLINIGEN LIMITED]15Current NDC, Legacy NDC, 3 package rows20241122_90e3da4e-3b1f-428b-99ca-e4bed1c80028.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSNa09299d5-9c55-4cef-aed0-3a6a4553228922
855613Foscavir 6000 MG in 250 mL InjectionPSNa09299d5-9c55-4cef-aed0-3a6a4553228922
855613250 ML foscarnet sodium 24 MG/ML Injection [Foscavir]SBDa09299d5-9c55-4cef-aed0-3a6a4553228922
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCDa09299d5-9c55-4cef-aed0-3a6a4553228922
855613250 ML Foscavir 24 MG/ML InjectionSYa09299d5-9c55-4cef-aed0-3a6a4553228922
1734377foscarnet sodium 6000 MG per 250 ML InjectionSYa09299d5-9c55-4cef-aed0-3a6a4553228922
855613Foscavir 6000 MG per 250 ML InjectionSYa09299d5-9c55-4cef-aed0-3a6a4553228922
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSN90e3da4e-3b1f-428b-99ca-e4bed1c8002816
855613Foscavir 6000 MG in 250 mL InjectionPSN90e3da4e-3b1f-428b-99ca-e4bed1c8002816
855613250 ML foscarnet sodium 24 MG/ML Injection [Foscavir]SBD90e3da4e-3b1f-428b-99ca-e4bed1c8002816
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCD90e3da4e-3b1f-428b-99ca-e4bed1c8002816
855613250 ML Foscavir 24 MG/ML InjectionSY90e3da4e-3b1f-428b-99ca-e4bed1c8002816
1734377foscarnet sodium 6000 MG per 250 ML InjectionSY90e3da4e-3b1f-428b-99ca-e4bed1c8002816
855613Foscavir 6000 MG per 250 ML InjectionSY90e3da4e-3b1f-428b-99ca-e4bed1c8002816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76310-024-457631000244510 POUCH in 1 CARTON (76310-024-45) > 1 BAG in 1 POUCH (76310-024-41) > 250 mL in 1 BAG10 pouch2021-04-060000-00-00NoNoCurrent