GLASSIA

Product NDC
0944-2884
11-digit product format
009442884
Labeler code
0944
Product ID
0944-2884_312a9f40-d4bd-4cc2-810a-2df7d7baead8
Type
PLASMA DERIVATIVE
Nonproprietary name
ALPHA.1-PROTEINASE INHIBITOR HUMAN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA125325
Marketing category
BLA
Marketing start
2010-07-01
Substance
.ALPHA.1-PROTEINASE INHIBITOR HUMAN
Active strength
1 g/50mL
Pharmacologic classes
Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
.ALPHA.1-PROTEINASE INHIBITOR HUMAN1 g/50mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2884-01GLASSIA1 in 1 CARTONINJECTION, SOLUTION131
0944-2884-02GLASSIA50 mL in 1 VIAL, GLASSINJECTION, SOLUTION5031
0944-2884-03GLASSIA1 in 1 CARTONINJECTION, SOLUTION131
0944-2884-04GLASSIA200 mL in 1 VIAL, GLASSINJECTION, SOLUTION20031
0944-2884-05GLASSIA1 in 1 CARTONINJECTION, SOLUTION131
0944-2884-06GLASSIA250 mL in 1 VIAL, GLASSINJECTION, SOLUTION25031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-2884-01EA - Each0944-28846234ccee-dced-4f84-83a1-e59f978225ba12012-07-24
0944-2884-02EA - Each0944-28845252d354-be53-4254-8d30-7e6e97734deb12019-02-13
0944-2884-03EA - Each0944-28843964a5f2-6a41-4997-9104-91a8db75382012025-07-08
0944-2884-04EA - Each0944-288479eb1c4f-ccf8-4200-88b7-99d095367daf12025-07-08
0944-2884-05EA - Each0944-28842250c3e7-3825-480f-a70a-de809db23dd412025-07-08
0944-2884-06EA - Each0944-288430c550c7-f6c8-4996-8f2f-f4b5f3501c6b12025-07-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2884GLASSIA (ALPHA.1-PROTEINASE INHIBITOR HUMAN) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]30Current NDC, Legacy NDC, 6 package rows20250316_83473cbb-48e4-42a2-81b6-4c851423da7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionPSN83473cbb-48e4-42a2-81b6-4c851423da7b31
1013867Glassia 1 MG InjectionPSN83473cbb-48e4-42a2-81b6-4c851423da7b31
1013867alpha 1-proteinase inhibitor, human 1 MG Injection [Glassia]SBD83473cbb-48e4-42a2-81b6-4c851423da7b31
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionSCD83473cbb-48e4-42a2-81b6-4c851423da7b31
1013867Glassia 1 MG InjectionSY83473cbb-48e4-42a2-81b6-4c851423da7b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0944-2884-01009442884011 VIAL, GLASS in 1 CARTON (0944-2884-01) / 50 mL in 1 VIAL, GLASS (0944-2884-02) 2010-07-010000-00-00NoNoCurrent
0944-2884-020094428840250 mL in 1 VIAL, GLASS50 mlHistorical
0944-2884-03009442884031 VIAL, GLASS in 1 CARTON (0944-2884-03) / 200 mL in 1 VIAL, GLASS (0944-2884-04) 2010-07-01NoNoHistorical
0944-2884-0400944288404200 mL in 1 VIAL, GLASS200 mlHistorical
0944-2884-05009442884051 VIAL, GLASS in 1 CARTON (0944-2884-05) / 250 mL in 1 VIAL, GLASS (0944-2884-06) 2010-07-01NoNoHistorical
0944-2884-0600944288406250 mL in 1 VIAL, GLASS250 mlHistorical