Home NDC 25021-189 Foscarnet Sodium
Product NDC 25021-189
11-digit product format 250210189
Labeler code 25021
Product ID 25021-189_f5829ec8-15e6-43a4-a5f0-68ea0cddb8c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Foscarnet Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA213001
Marketing category ANDA
Marketing start 2021-05-15
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 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 2026-08-18 06:07:40 2026-07 A213001-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213001-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213001-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213001-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-04-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213001-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-04-21 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A213001-001 CGT 2021-12-28 782e0a99824c…
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 25021-189-84 Foscarnet Sodium 10 in 1 CARTON INJECTION, SOLUTION 10 1 25021-189-84 Foscarnet Sodium 250 mL in 1 BAG INJECTION, SOLUTION 250 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-189 FOSCARNET SODIUM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 1 Current NDC, Legacy NDC, 2 package rows 20210515_2f49c1bc-0828-4e5c-a3c0-81e997213b0e.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 · 3 matching rows.
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 25021-189-84 25021018984 10 BAG in 1 CARTON (25021-189-84) / 250 mL in 1 BAG 10 bag 2021-05-15 0000-00-00 No No Current