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 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
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
2026-08-18 06:07:402026-07A216602-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2024-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216602-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2024-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216602-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2024-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-018072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216602-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2024-03-016a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216602-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2024-03-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216602-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216602-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216602-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216602-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216602-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216602-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216602-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216602-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216602-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216602-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216602-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216602-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216602-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216602-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216602-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216602-001AP16a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216602-001AP1a50c72e98297…

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
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

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 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

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