FDA.reportPublic FDA data

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1597262Internal RxNorm lookup
1597267Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
38b482a8-960b-4591-9857-5031ecb830aaAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLINCYTOBLINATUMOMABAmgen, Inc38b482a8-960b-4591-9857-5031ecb830aa2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125557
ndc (product): 55513-160

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125557Blincytoblinatumomab351(a)Rx2026-07-01

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 kit2026-04-30NoNoCurrent