Bleomycin

Product NDC
71288-106
11-digit product format
712880106
Labeler code
71288
Product ID
71288-106_322a4cec-4797-49a9-b880-ea80fdb133f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bleomycin Sulfate
Dosage form
POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA205030
Marketing category
ANDA
Marketing start
2018-08-31
Substance
BLEOMYCIN SULFATE
Active strength
15 [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 SULFATE15 [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
71288-106-10Bleomycin15 in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION153
71288-106-10Bleomycin1 in 1 CARTONPOWDER, FOR SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-106-10EA - Each71288-1067684103e-64f3-4ca4-bb68-5f4e7bc41c1c12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-106BLEOMYCIN (BLEOMYCIN SULFATE) POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20210626_640602f9-a7df-46f0-a9b1-19c471008bee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726673bleomycin 15 UNT InjectionPSN640602f9-a7df-46f0-a9b1-19c471008bee3
1726676bleomycin 30 UNT InjectionPSN640602f9-a7df-46f0-a9b1-19c471008bee3
1726673bleomycin 15 UNT InjectionSCD640602f9-a7df-46f0-a9b1-19c471008bee3
1726676bleomycin 30 UNT InjectionSCD640602f9-a7df-46f0-a9b1-19c471008bee3
1726673bleomycin (as bleomycin sulfate) 15 UNT InjectionSY640602f9-a7df-46f0-a9b1-19c471008bee3
1726676bleomycin (as bleomycin sulfate) 30 UNT InjectionSY640602f9-a7df-46f0-a9b1-19c471008bee3
1726673bleopmycin 15,000 IU InjectionSY640602f9-a7df-46f0-a9b1-19c471008bee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-106-10712880106101 VIAL, SINGLE-DOSE in 1 CARTON (71288-106-10) / 15 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2018-08-310000-00-00NoNoCurrent