FDA.reportPublic FDA data

Zinecard

Product NDC
0013-8727
11-digit product format
000138727
Labeler code
0013
Product ID
0013-8727_44866db3-8132-4de9-a006-5e350fdb5e9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexrazoxane
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacia and Upjohn Company LLC
Application
NDA020212
Marketing category
NDA
Marketing start
1995-05-26
Marketing end
0000-00-00
Substance
DEXRAZOXANE HYDROCHLORIDE
Active strength
500 mg/50mL
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0013-8727DDiscontinued by firm2026-07-31
excluded packagepackage0013-87270013-8727-89DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020212-001ZINECARDDEXRAZOXANE HYDROCHLORIDEEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-05-26
N020212-002ZINECARDDEXRAZOXANE HYDROCHLORIDEEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-05-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020212-001ZINECARDEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-05-26a50c72e98297…
2026-08-01 22:54:322026-06N020212-002ZINECARDEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1995-05-26a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-8727-89EA - Each0013-8727dfead0f4-5b1e-46b5-b0d0-d4d65d21a8ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXRAZOXANE HYDROCHLORIDEACTIVE INGREDIENT5346058Q7SZINECARD (DEXRAZOXANE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY]10
DEXRAZOXANEACTIVE MOIETY048L81261FZINECARD (DEXRAZOXANE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY]10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBZINECARD (DEXRAZOXANE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY]10