BLINCYTO

Product NDC
55513-160
11-digit product format
555130160
Labeler code
55513
Product ID
55513-160_4a2c4b49-a991-4ac7-80b3-4b2f8f62de30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
blinatumomab
Dosage form
KIT
Labeler
Amgen, Inc
Application
BLA125557
Marketing category
BLA
Marketing start
2014-12-18
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1597262, 1597267

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
567acdef-80dd-4f85-b494-c62c29cc9980Product name120150227

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-150-01BLINCYTO3.088 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,3.088 mL12.5 ug in 1mL42
55513-160-01BLINCYTO1 in 1 PACKAGEKIT142
55513-160-21BLINCYTO1 in 1 PACKAGEKIT142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-160-01EA - Each55513-1606e74e793-a88c-4ade-87f4-99f772bc5b8512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BLINATUMOMABACTIVE INGREDIENT4FR53SIF3ABLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
BLINATUMOMABACTIVE MOIETY4FR53SIF3ABLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
LYSINE HYDROCHLORIDEINACTIVE INGREDIENTJNJ23Q2COMBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7
TREHALOSE DIHYDRATEINACTIVE INGREDIENT7YIN7J07X4BLINCYTO (BLINATUMOMAB) KIT [AMGEN INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-160BLINCYTO (BLINATUMOMAB) KIT [AMGEN, INC]40Current NDC, Legacy NDC, 3 package rows20250511_38b482a8-960b-4591-9857-5031ecb830aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597262blinatumomab 35 MCG InjectionPSN38b482a8-960b-4591-9857-5031ecb830aa42
1597267Blincyto 35 MCG InjectionPSN38b482a8-960b-4591-9857-5031ecb830aa42
1597267blinatumomab 0.035 MG Injection [Blincyto]SBD38b482a8-960b-4591-9857-5031ecb830aa42
1597262blinatumomab 0.035 MG InjectionSCD38b482a8-960b-4591-9857-5031ecb830aa42
1597262blinatumomab 35 MCG InjectionSY38b482a8-960b-4591-9857-5031ecb830aa42
1597267Blincyto 0.035 MG InjectionSY38b482a8-960b-4591-9857-5031ecb830aa42
1597267Blincyto 35 MCG InjectionSY38b482a8-960b-4591-9857-5031ecb830aa42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-150-01555130150013.088 mL in 1 VIAL3.088 mlHistorical
55513-160-01555130160011 KIT in 1 PACKAGE (55513-160-01) * 3.088 mL in 1 VIAL (55513-150-01) * 10.6 mL in 1 VIAL (55513-155-01) 1 kit2014-12-180000-00-00NoNoCurrent
55513-160-21555130160211 KIT in 1 PACKAGE (55513-160-21) * 3.088 mL in 1 VIAL (55513-150-01) * 10.6 mL in 1 VIAL (55513-155-01) 1 kit2026-04-30NoNoHistorical