Carmustine

Product NDC
46708-659
11-digit product format
467080659
Labeler code
46708
Product ID
46708-659_6e0cfe79-6998-45b2-bceb-f8848624be5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carmustine
Dosage form
KIT
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215730
Marketing category
ANDA
Marketing start
2023-10-20
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
46708-658-31Carmustine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,30 mL100 mg in 30mL1
46708-659-02Carmustine1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-659CARMUSTINE KIT [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20231117_6e0cfe79-6998-45b2-bceb-f8848624be5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309012carmustine 100 MG InjectionPSN6e0cfe79-6998-45b2-bceb-f8848624be5a1
309012carmustine 100 MG InjectionSCD6e0cfe79-6998-45b2-bceb-f8848624be5a1
309012BCNU 100 MG InjectionSY6e0cfe79-6998-45b2-bceb-f8848624be5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-658-314670806583130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
46708-659-02467080659021 KIT in 1 CARTON (46708-659-02) * 30 mL in 1 VIAL, SINGLE-DOSE (46708-658-31) * 3 mL in 1 VIAL (46708-660-03) 1 kit2023-10-20NoNoCurrent