Aralast

Product NDC
0944-2814
11-digit product format
009442814
Labeler code
0944
Product ID
0944-2814_20ede125-2505-4088-8f5e-c6d2d5c7c80a
Type
PLASMA DERIVATIVE
Nonproprietary name
Alpha-1-Proteinase Inhibitor (Human)
Dosage form
KIT
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA125039
Marketing category
BLA
Marketing start
2002-12-23
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aralast
Brand name suffix
NP
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2803-03AralastNP25 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,25 mL16 mg in 1mL20
0944-2814-01AralastNP1 in 1 CARTONKIT120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-2814-01EA - Each0944-281484be460f-672a-41af-9513-9348ee30ef9d12014-06-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2814ARALAST NP (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]18Current NDC, Legacy NDC, 2 package rows20241121_a9a5b46e-04da-41bd-bb5f-c4936b664fef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionPSNa9a5b46e-04da-41bd-bb5f-c4936b664fef20
1233711Aralast NP 1 MG InjectionPSNa9a5b46e-04da-41bd-bb5f-c4936b664fef20
1233711alpha 1-proteinase inhibitor, human 1 MG Injection [Aralast]SBDa9a5b46e-04da-41bd-bb5f-c4936b664fef20
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionSCDa9a5b46e-04da-41bd-bb5f-c4936b664fef20
1233711Aralast 1 MG InjectionSYa9a5b46e-04da-41bd-bb5f-c4936b664fef20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0944-2803-030094428030325 mL in 1 VIAL25 mlHistorical
0944-2814-01009442814011 KIT in 1 CARTON (0944-2814-01) * 25 mL in 1 VIAL, GLASS (64764-518-25) * 25 mL in 1 VIAL (0944-2803-03) 1 kit2002-12-230000-00-00NoNoCurrent