Home NDC 63323-875-50 Foscarnet
Product NDC 63323-875
Requested package NDC 63323-875-50
11-digit product format 633230875
Labeler code 63323
Product ID 63323-875_773fcafd-38ca-4aeb-9ecd-e7d436560ddb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name foscarnet sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA212483
Marketing category ANDA
Marketing start 2021-01-29
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 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 A212483-001 FOSCARNET SODIUM FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212483-001 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 2024-06-18 03:08 UTC · 2 captures of this ZIP 2024-06 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212483-001 FOSCARNET SODIUM 2.4GM/100ML INJECTABLE / INJECTION AP 2021-01-29 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A212483-001 FOSCARNET SODIUM 6GM/250ML (24MG/ML) SOLUTION / INTRAVENOUS AP 2021-01-29 a50c72e98297…
Observed Orange Book normalized TE history# 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
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 63323-875-50 Foscarnet 1 in 1 CARTON INJECTION, SOLUTION 1 3 63323-875-50 Foscarnet 250 mL in 1 BOTTLE INJECTION, SOLUTION 250 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-875 FOSCARNET (FOSCARNET SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20210623_335f7deb-a045-43cb-b319-d7b73bfda73c.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 63323-875-50 63323087550 1 BOTTLE in 1 CARTON (63323-875-50) / 250 mL in 1 BOTTLE 1 bottle 2021-01-29 0000-00-00 No No Current