FDA.reportPublic FDA data

Dacarbazine

Product NDC
71288-174
11-digit product format
712880174
Labeler code
71288
Product ID
71288-174_94e81c40-cf9b-45fa-a396-044196081d48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dacarbazine
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA075259
Marketing category
ANDA
Marketing start
2024-04-22
Substance
DACARBAZINE
Active strength
200 mg/20mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dacarbazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DACARBAZINE200 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7GR28W0FJI
Rxcui1731338

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
21263ae2-912c-bf52-bf34-9ea80b3e11b9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-174-20Dacarbazine20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION201
71288-174-21Dacarbazine10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-174-20EA - Each71288-1747d2a5e5c-f919-4557-a68e-bbe05684f30812024-05-16
71288-174-21EA - Each71288-1744c65a5f1-2590-4c19-b165-31d994f2869012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-174DACARBAZINE INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240423_64037f45-6245-49f0-9ae8-18d75753ae1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731338dacarbazine 200 MG InjectionPSN64037f45-6245-49f0-9ae8-18d75753ae1f1
1731338dacarbazine 200 MG InjectionSCD64037f45-6245-49f0-9ae8-18d75753ae1f1
1731338dacarbazine (as dacarbazine citrate) 200 MG InjectionSY64037f45-6245-49f0-9ae8-18d75753ae1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-174-207128801742020 mL in 1 VIAL, SINGLE-USE20 mlHistorical
71288-174-217128801742110 VIAL, SINGLE-USE in 1 CARTON (71288-174-21) / 20 mL in 1 VIAL, SINGLE-USE (71288-174-20) 2024-04-22NoNoHistorical