Home NDC 68083-195 Dexrazoxane
Product NDC 68083-195
11-digit product format 680830195
Labeler code 68083
Product ID 68083-195_31a8c608-3ad6-44fe-aec8-621a8b991677
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexrazoxane for Injection
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA207321
Marketing category ANDA
Marketing start 2016-12-05
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 A207321-001 DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 A207321-002 DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16
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.
Product history page 1 of 2 · 80 observed 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 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207321-002 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2019-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207321-001 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-11-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 68083-195-01 Dexrazoxane 50 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 50 6 68083-195-01 Dexrazoxane 01 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 01 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-195 DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20231214_c9c625fc-8852-4ed4-bcf2-63f46a706782.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 · 4 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 68083-195-01 68083019501 1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL 1 vial 2016-12-05 0000-00-00 No No Current