Home NDC 0143-9192 Foscarnet Sodium
Product NDC 0143-9192
11-digit product format 001439192
Labeler code 0143
Product ID 0143-9192_148361f3-4366-9f0f-e063-6394a90a69e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name foscarnet sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA213987
Marketing category ANDA
Marketing start 2023-11-29
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213987-001 FOSCARNET SODIUM FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2023-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213987-001 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 2026-08-18 06:07:40 2026-07 A213987-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2023-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213987-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2023-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213987-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2023-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213987-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2023-11-29 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213987-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2023-11-29 a50c72e98297…
Observed Orange Book normalized TE history# 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 0143-9192-01 Foscarnet Sodium 10 in 1 CASE INJECTION, SOLUTION 10 2 0143-9192-01 Foscarnet Sodium 1 in 1 CARTON INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9192 FOSCARNET SODIUM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, 2 package rows 20240404_b612e6f1-584f-4188-b96e-1a9adfcfe75c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9192-01 00143919201 10 CARTON in 1 CASE (0143-9192-01) / 1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE 10 carton 2023-11-29 No No Current