TRETTEN

Product NDC
0169-7013
11-digit product format
001697013
Labeler code
0169
Product ID
0169-7013_7e42c015-2e0e-4488-8b8a-3ab37035b2f3
Type
PLASMA DERIVATIVE
Nonproprietary name
Coagulation Factor XIII A-Subunit (Recombinant)
Dosage form
KIT
Labeler
Novo Nordisk
Application
BLA125398
Marketing category
BLA
Marketing start
2013-12-23
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-7013-01TRETTEN1 in 1 KITKIT18
0169-7113-11TRETTEN3 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1 mL2500 [iU] in 3mL8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-7013-01EA - Each0169-7013cc190372-e012-4d75-88ab-d00d6bb0a99912014-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-7013TRETTEN (COAGULATION FACTOR XIII A-SUBUNIT (RECOMBINANT)) KIT [NOVO NORDISK]8Current NDC, Legacy NDC, 2 package rows20200714_8664978e-1814-4930-aca5-97a24455f6df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488302coagulation factor XIII a-subunit (recombinant) 1 UNT InjectionPSN8664978e-1814-4930-aca5-97a24455f6df8
1488304Tretten 1 UNT InjectionPSN8664978e-1814-4930-aca5-97a24455f6df8
1488304coagulation factor XIII a-subunit (recombinant) 1 UNT Injection [Tretten]SBD8664978e-1814-4930-aca5-97a24455f6df8
1488302coagulation factor XIII a-subunit (recombinant) 1 UNT InjectionSCD8664978e-1814-4930-aca5-97a24455f6df8
1488304Tretten 1 UNT InjectionSY8664978e-1814-4930-aca5-97a24455f6df8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-7013-01001697013011 KIT in 1 KIT (0169-7013-01) * 3 mL in 1 VIAL, GLASS (0169-7113-11) * 3.2 mL in 1 VIAL, GLASS (0169-7000-93) 1 kit2013-12-230000-00-00NoNoCurrent
0169-7113-11001697113113 mL in 1 VIAL, GLASS3 mlHistorical