Carmustine

Product NDC
62332-659
11-digit product format
623320659
Labeler code
62332
Product ID
62332-659_d3e57606-6818-49db-911e-c6b664a2dd59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carmustine
Dosage form
KIT
Labeler
Alembic Pharmaceuticals Inc.
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
62332-658-31Carmustine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,30 mL100 mg in 30mL3
62332-659-02Carmustine1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-659-02EA - Each62332-6596d279f62-cef8-4fab-a27f-d7ae0f1cb67812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-659CARMUSTINE KIT [ALEMBIC PHARMACEUTICALS INC.]3Current NDC, 2 package rows20231110_cd2bd05c-c56a-46d2-b698-e085e289de95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309012carmustine 100 MG InjectionPSNcd2bd05c-c56a-46d2-b698-e085e289de953
309012carmustine 100 MG InjectionSCDcd2bd05c-c56a-46d2-b698-e085e289de953
309012BCNU 100 MG InjectionSYcd2bd05c-c56a-46d2-b698-e085e289de953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-658-316233206583130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
62332-659-02623320659021 KIT in 1 CARTON (62332-659-02) * 30 mL in 1 VIAL, SINGLE-DOSE (62332-658-31) * 3 mL in 1 VIAL (62332-660-03) 1 kit2023-10-20NoNoCurrent