FDA.reportPublic FDA data

Dacarbazine

Product NDC
63323-127
11-digit product format
633230127
Labeler code
63323
Product ID
63323-127_04644165-06c9-4a55-a026-a529d824cc90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DACARBAZINE
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075371
Marketing category
ANDA
Marketing start
2001-09-07
Substance
DACARBAZINE
Active strength
10 mg/mL
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
DACARBAZINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7GR28W0FJI
Rxcui1731338, 1731340

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
63323-127-00Dacarbazine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION104
63323-127-10Dacarbazine10 in 1 TRAYINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-127-00EA - Each63323-1279030847d-b3da-4929-b2a5-df9cc6a4fae412023-10-16
63323-127-10EA - Each63323-1274adc01d1-8f6e-429c-8a76-f572d71ddd5312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DACARBAZINEACTIVE INGREDIENT7GR28W0FJIDACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
DACARBAZINEACTIVE MOIETY7GR28W0FJIDACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-127DACARBAZINE (DACARBAZINE) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20221029_b6b97e41-5f15-498c-abfb-d8443ea4d216.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731340dacarbazine 100 MG InjectionPSNb6b97e41-5f15-498c-abfb-d8443ea4d2164
1731338dacarbazine 200 MG InjectionPSNb6b97e41-5f15-498c-abfb-d8443ea4d2164
1731340dacarbazine 100 MG InjectionSCDb6b97e41-5f15-498c-abfb-d8443ea4d2164
1731338dacarbazine 200 MG InjectionSCDb6b97e41-5f15-498c-abfb-d8443ea4d2164
1731338dacarbazine (as dacarbazine citrate) 200 MG InjectionSYb6b97e41-5f15-498c-abfb-d8443ea4d2164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-127-006332301270010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-127-106332301271010 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00) 2001-09-070000-00-00NoNoCurrent