Home NDC 65145-191 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220068-001 FOSCARNET SODIUM FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2026-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220068-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A220068-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2026-05-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A220068-001 AP 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Foscarnet Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSCARNET SODIUM 24 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 964YS0OOG1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65145-191-01 Foscarnet Sodium 250 mL in 1 BAG INJECTION, SOLUTION 250 1 65145-191-01 Foscarnet Sodium 1 in 1 POUCH INJECTION, SOLUTION 1 1 65145-191-10 Foscarnet Sodium 10 in 1 CASE INJECTION, SOLUTION 10 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65145-191-01 65145019101 250 mL in 1 BAG 250 ml Historical 65145-191-10 65145019110 10 POUCH in 1 CASE (65145-191-10) / 1 BAG in 1 POUCH (65145-191-01) / 250 mL in 1 BAG 10 pouch 2026-05-20 No No Current