carmustine

Product NDC
70121-1482
11-digit product format
701211482
Labeler code
70121
Product ID
70121-1482_811400a5-1133-45dc-8b6f-23e74c92d206
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carmustine
Dosage form
KIT
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA211229
Marketing category
ANDA
Marketing start
2018-10-22
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui309012

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bae01308-1b8b-469d-b5f8-5f7855ef8376Product name720250716
8f5e4eb6-eb6b-45c2-b18a-1d6819bcb788Product name120230125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1482-2carmustine1 in 1 CARTONKIT18
70121-1668-1carmustine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,30 mL100 mg in 30mL8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1482-2EA - Each70121-1482c8c2fcac-c83d-4e41-bb0c-10c7dc49793812018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1482CARMUSTINE KIT [AMNEAL PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 2 package rows20231104_2df937ad-a458-4030-bb7b-4468baa3685e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309012carmustine 100 MG InjectionPSN2df937ad-a458-4030-bb7b-4468baa3685e8
309012carmustine 100 MG InjectionSCD2df937ad-a458-4030-bb7b-4468baa3685e8
309012BCNU 100 MG InjectionSY2df937ad-a458-4030-bb7b-4468baa3685e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1482-2701211482021 KIT in 1 CARTON (70121-1482-2) * 3 mL in 1 VIAL (70121-3639-1) * 30 mL in 1 VIAL, SINGLE-DOSE (70121-1668-1) 1 kit2018-10-220000-00-00NoNoCurrent
70121-1668-17012116680130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical