Home NDC 72205-248 Dexrazoxane
Product NDC 72205-248
11-digit product format 722050248
Labeler code 72205
Product ID 72205-248_bdcb7617-046b-4db9-94ba-b10102565868
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexrazoxane
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Novadoz Pharmaceuticals LLC
Application ANDA216748
Marketing category ANDA
Marketing start 2025-03-26
Substance DEXRAZOXANE HYDROCHLORIDE
Active strength 500 mg/50mL
Pharmacologic classes Cytoprotective Agent [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216748-001 DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 A216748-002 DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A216748-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216748-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216748-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216748-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216748-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216748-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216748-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216748-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216748-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216748-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2025-03-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dexrazoxane
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXRAZOXANE HYDROCHLORIDE 500 mg/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5346058Q7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1736585 Internal RxNorm lookup 1736590 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 72205-248-01 Dexrazoxane 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 50 2 72205-248-01 Dexrazoxane 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-248 DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, 2 package rows 20250410_a7c01089-85f5-40aa-b679-f53a425b4d68.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 Marketing start Sample Exclude flag Status 72205-248-01 72205024801 1 VIAL, SINGLE-DOSE in 1 CARTON (72205-248-01) / 50 mL in 1 VIAL, SINGLE-DOSE 2025-04-09 No No Current