NDC 13533-335

GamaSTAN

Immune Globulin (human)

GamaSTAN is a Intramuscular Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Immunoglobulin G.

• Product ID: 13533-335_38a323af-7c25-42d1-9c29-532ef61999b8
• NDC: 13533-335
• Product Type: Plasma Derivative
• Proprietary Name: GamaSTAN
• Generic Name: Immune Globulin (human)
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-02-05
• Marketing Category: BLA / BLA
• Application Number: BLA101134
• Labeler Name: GRIFOLS USA, LLC
• Substance Name: HUMAN IMMUNOGLOBULIN G
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 13533-335-04

1 VIAL in 1 CARTON (13533-335-04) > 2 mL in 1 VIAL (13533-335-40)

• Marketing Start Date: 2018-02-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13533-335-04 [13533033504]

GamaSTAN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101134
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2018-02-05

NDC 13533-335-13 [13533033513]

GamaSTAN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101134
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2018-02-05

NDC 13533-335-40 [13533033540]

GamaSTAN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101134
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2018-02-05

NDC 13533-335-12 [13533033512]

GamaSTAN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA101134
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2018-02-05

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	.165 g/mL

Pharmacological Class

• Human Immunoglobulin G [EPC]
• Passively Acquired Immunity [PE]
• Antigen Neutralization [MoA]
• Immunoglobulins [CS]

NDC Crossover Matching brand name "GamaSTAN" or generic name "Immune Globulin (human)"

NDC	Brand Name	Generic Name
13533-335	GamaSTAN	immune globulin (human)
13533-635	GAMASTAN	IMMUNE GLOBULIN (HUMAN)
61953-0004	Flebogamma	Immune Globulin (Human)
76125-900	GAMMAKED	Immune Globulin (Human)
13533-800	Gamunex-C	Immune Globulin (Human)