Bleomycin

Product NDC
16714-908
11-digit product format
167140908
Labeler code
16714
Product ID
16714-908_c3601b94-30e6-4651-a9da-f6a70e907314
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bleomycin
Dosage form
POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
NorthStar Rx LLC
Application
ANDA205030
Marketing category
ANDA
Marketing start
2018-12-01
Substance
BLEOMYCIN SULFATE
Active strength
30 [USP'U]/1
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bleomycin
Listing expiration
2027-12-31

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
16714-908-01Bleomycin30 in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION305
16714-908-01Bleomycin1 in 1 CARTONPOWDER, FOR SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-908-01EA - Each16714-908ecc2959a-18c2-4c39-ae8b-508b827493e212019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-908BLEOMYCIN POWDER, FOR SOLUTION [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 2 package rows20211208_6824b1e1-e5fa-4371-ade9-1346e12ab0c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726673bleomycin 15 UNT InjectionPSN6824b1e1-e5fa-4371-ade9-1346e12ab0c75
1726676bleomycin 30 UNT InjectionPSN6824b1e1-e5fa-4371-ade9-1346e12ab0c75
1726673bleomycin 15 UNT InjectionSCD6824b1e1-e5fa-4371-ade9-1346e12ab0c75
1726676bleomycin 30 UNT InjectionSCD6824b1e1-e5fa-4371-ade9-1346e12ab0c75
1726673bleomycin (as bleomycin sulfate) 15 UNT InjectionSY6824b1e1-e5fa-4371-ade9-1346e12ab0c75
1726676bleomycin (as bleomycin sulfate) 30 UNT InjectionSY6824b1e1-e5fa-4371-ade9-1346e12ab0c75
1726673bleopmycin 15,000 IU InjectionSY6824b1e1-e5fa-4371-ade9-1346e12ab0c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-908-01167140908011 VIAL, SINGLE-DOSE in 1 CARTON (16714-908-01) / 30 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2018-12-010000-00-00NoNoCurrent