foscarnet sodium

Product NDC
23155-771
11-digit product format
231550771
Labeler code
23155
Product ID
23155-771_7de2fbfd-a1c3-4320-8212-bfeeff0a20a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
foscarnet sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA213807
Marketing category
ANDA
Marketing start
2023-06-05
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage23155-77123155-771-41DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage23155-77123155-771-41DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage23155-77123155-771-41DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A213807-001FOSCARNET SODIUMFOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213807-001AP

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 06:07:402026-07A213807-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213807-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213807-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-058072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213807-001FOSCARNET SODIUM2.4GM/100MLINJECTABLE / INJECTIONAP2023-06-053f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213807-001FOSCARNET SODIUM6GM/250ML (24MG/ML)SOLUTION / INTRAVENOUSAP2023-06-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213807-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213807-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213807-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213807-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213807-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213807-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213807-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213807-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213807-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213807-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213807-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213807-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213807-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213807-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213807-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213807-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213807-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213807-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213807-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213807-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213807-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213807-001AP13f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213807-001AP1a50c72e98297…

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
d2b4ce68-5a81-4b14-8914-21bc38f01008Available 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
23155-771-31foscarnet sodium250 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION2504
23155-771-31foscarnet sodium1 in 1 CARTONINJECTION, SOLUTION14
23155-771-41foscarnet sodium10 in 1 CARTONINJECTION, SOLUTION104
23155-771-41foscarnet sodium250 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION2504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-771-31ML - Milliliter23155-7718f2da777-999c-4195-bd5a-e6c235feb38912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-771FOSCARNET SODIUM INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, 4 package rows20250330_d2b4ce68-5a81-4b14-8914-21bc38f01008.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 SODIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d2b4ce68-5a81-4b14-8914-21bc38f010082025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213807
application number: ANDA213807
ndc (product): 23155-771

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734377foscarnet sodium 6000 MG in 250 ML InjectionPSNd2b4ce68-5a81-4b14-8914-21bc38f010084
1734377250 ML foscarnet sodium 24 MG/ML InjectionSCDd2b4ce68-5a81-4b14-8914-21bc38f010084
1734377foscarnet sodium 6000 MG per 250 ML InjectionSYd2b4ce68-5a81-4b14-8914-21bc38f010084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-771-31231550771311 BOTTLE, GLASS in 1 CARTON (23155-771-31) / 250 mL in 1 BOTTLE, GLASS2023-06-05NoNoCurrent
23155-771-412315507714110 in 1 CARTONHistorical