NDC 0944-2884

GLASSIA

.alpha.1-proteinase Inhibitor Human

GLASSIA is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Baxalta Us Inc.. The primary component is .alpha.1-proteinase Inhibitor Human.

• Product ID: 0944-2884_08d8f23f-5ecb-431c-bb45-0183756d7a8b
• NDC: 0944-2884
• Product Type: Plasma Derivative
• Proprietary Name: GLASSIA
• Generic Name: .alpha.1-proteinase Inhibitor Human
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-07-01
• Marketing Category: BLA / BLA
• Application Number: BLA125325
• Labeler Name: Baxalta US Inc.
• Substance Name: .ALPHA.1-PROTEINASE INHIBITOR HUMAN
• Active Ingredient Strength: 1 g/50mL
• Pharm Classes: Human alpha-1 Proteinase Inhibitor [EPC], Trypsin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0944-2884-01

1 VIAL, GLASS in 1 CARTON (0944-2884-01) > 50 mL in 1 VIAL, GLASS (0944-2884-02)

• Marketing Start Date: 2010-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0944-2884-02 [00944288402]

GLASSIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125325
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2014-04-04

NDC 0944-2884-01 [00944288401]

GLASSIA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125325
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2010-07-01

Drug Details

Active Ingredients

Ingredient	Strength
.ALPHA.1-PROTEINASE INHIBITOR HUMAN	1 g/50mL

Pharmacological Class

• Human alpha-1 Proteinase Inhibitor [EPC]
• Trypsin Inhibitors [MoA]
• Human alpha-1 Proteinase Inhibitor [EPC]
• Trypsin Inhibitors [MoA]

NDC Crossover Matching brand name "GLASSIA" or generic name ".alpha.1-proteinase Inhibitor Human"

NDC	Brand Name	Generic Name
0944-2884	GLASSIA	.ALPHA.1-PROTEINASE INHIBITOR HUMAN
0053-7202	ZEMAIRA	.ALPHA.1-PROTEINASE INHIBITOR HUMAN
0053-7203	ZEMAIRA	.ALPHA.1-PROTEINASE INHIBITOR HUMAN