Carmustine

Product NDC
71288-126
11-digit product format
712880126
Labeler code
71288
Product ID
71288-126_ddf050d8-5626-4ee0-99dd-bd44146b144e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carmustine
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA213460
Marketing category
ANDA
Marketing start
2021-08-02
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
71288-124-30Carmustine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,30 mL100 mg in 30mL6
71288-126-90Carmustine1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-126-90EA - Each71288-1265c68a21e-ac50-49dc-b4ce-28ef4d74fadb12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-126CARMUSTINE KIT [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20231115_37a16d53-6a0d-4d24-a5f9-e8824b244b48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309012carmustine 100 MG InjectionPSN37a16d53-6a0d-4d24-a5f9-e8824b244b486
309012carmustine 100 MG InjectionSCD37a16d53-6a0d-4d24-a5f9-e8824b244b486
309012BCNU 100 MG InjectionSY37a16d53-6a0d-4d24-a5f9-e8824b244b486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-124-307128801243030 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
71288-126-90712880126901 KIT in 1 CARTON (71288-126-90) * 30 mL in 1 VIAL, SINGLE-DOSE (71288-124-30) * 3 mL in 1 VIAL (71288-125-03) 1 kit2021-08-020000-00-00NoNoCurrent