Home NDC 68083-389 Foscarnet Sodium
Product NDC 68083-389
11-digit product format 680830389
Labeler code 68083
Product ID 68083-389_e7d4415b-96cc-4f7b-b639-7369baf4871a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Foscarnet Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA213001
Marketing category ANDA
Marketing start 2021-04-21
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 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 A213001-001 FOSCARNET SODIUM FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213001-001 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 A213001-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-04-21 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 A213001-001 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Foscarnet Sodium
Listing expiration 2026-12-31 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 68083-389-01 Foscarnet Sodium 1 in 1 CARTON INJECTION, SOLUTION 1 5 68083-389-01 Foscarnet Sodium 250 mL in 1 BAG INJECTION, SOLUTION 250 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-389 FOSCARNET SODIUM INJECTION, SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20210425_d4048736-389f-48d8-aadd-6bc76d604ddb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68083-389-01 68083038901 1 BAG in 1 CARTON (68083-389-01) / 250 mL in 1 BAG 1 bag 2021-04-21 0000-00-00 No No Current