Bleomycin

Product NDC
0143-9241
11-digit product format
001439241
Labeler code
0143
Product ID
0143-9241_c8047994-3b3a-4e16-809b-786e47014fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bleomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065042
Marketing category
ANDA
Marketing start
2018-01-09
Substance
BLEOMYCIN SULFATE
Active strength
30 [USP'U]/1
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLEOMYCIN SULFATE30 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7DP3NTV15T
Rxcui1726673, 1726676

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee93f825-270c-1e25-534e-aae72a8b5314Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9241-01Bleomycin1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16
0143-9241-01Bleomycin1 in 1 BOX, UNIT-DOSEINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9241-01EA - Each0143-92412fe56d60-d280-4d09-a92f-1335b34335fd12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9241BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20240413_cccfb763-79fa-4186-89fb-d8d061d3c161.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726673bleomycin 15 UNT InjectionPSNcccfb763-79fa-4186-89fb-d8d061d3c1616
1726676bleomycin 30 UNT InjectionPSNcccfb763-79fa-4186-89fb-d8d061d3c1616
1726673bleomycin 15 UNT InjectionSCDcccfb763-79fa-4186-89fb-d8d061d3c1616
1726676bleomycin 30 UNT InjectionSCDcccfb763-79fa-4186-89fb-d8d061d3c1616
1726673bleomycin (as bleomycin sulfate) 15 UNT InjectionSYcccfb763-79fa-4186-89fb-d8d061d3c1616
1726676bleomycin (as bleomycin sulfate) 30 UNT InjectionSYcccfb763-79fa-4186-89fb-d8d061d3c1616
1726673bleopmycin 15,000 IU InjectionSYcccfb763-79fa-4186-89fb-d8d061d3c1616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9241-01001439241011 VIAL in 1 BOX, UNIT-DOSE (0143-9241-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2018-01-090000-00-00NoNoCurrent