carmustine

Product NDC
43598-628
11-digit product format
435980628
Labeler code
43598
Product ID
43598-628_b5eebc2d-a329-0d52-d14c-a68bdf446ca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carmustine
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA213207
Marketing category
ANDA
Marketing start
2021-10-04
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
43598-628-57carmustine1 in 1 CARTONKIT15
43598-861-11carmustine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,30 mL100 mg in 30mL5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-628-57EA - Each43598-6289e5bf613-2aa1-49c0-8d9b-1904a1050ac412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-628CARMUSTINE KIT [DR. REDDY'S LABORATORIES INC.]5Current NDC, Legacy NDC, 2 package rows20250117_b946c396-34fc-1845-1944-f16028a8447d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309012carmustine 100 MG InjectionPSNb946c396-34fc-1845-1944-f16028a8447d5
309012carmustine 100 MG InjectionSCDb946c396-34fc-1845-1944-f16028a8447d5
309012BCNU 100 MG InjectionSYb946c396-34fc-1845-1944-f16028a8447d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-628-57435980628571 KIT in 1 CARTON (43598-628-57) * 3 mL in 1 VIAL (43598-860-11) * 30 mL in 1 VIAL, SINGLE-DOSE (43598-861-11) 1 kit2021-10-040000-00-00NoNoCurrent
43598-861-114359808611130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical