NDC 61953-0004

Flebogamma DIF

Immune Globulin (human)

Flebogamma DIF is a Intravenous 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: 61953-0004_1f8c566e-d36b-469d-b6e0-ba2011a8b1f8
• NDC: 61953-0004
• Product Type: Plasma Derivative
• Proprietary Name: Flebogamma DIF
• Generic Name: Immune Globulin (human)
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2006-12-21
• Marketing Category: BLA / BLA
• Application Number: BLA125077
• Labeler Name: GRIFOLS USA, LLC
• Substance Name: HUMAN IMMUNOGLOBULIN G
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61953-0004-1

1 VIAL in 1 CARTON (61953-0004-1) > 10 mL in 1 VIAL (61953-0004-6)

• Marketing Start Date: 2006-12-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61953-0004-7 [61953000407]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-11-14

NDC 61953-0004-5 [61953000405]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2006-12-21

NDC 61953-0004-6 [61953000406]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-11-14

NDC 61953-0004-4 [61953000404]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2006-12-21

NDC 61953-0004-8 [61953000408]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-11-14

NDC 61953-0004-2 [61953000402]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2006-12-21

NDC 61953-0004-3 [61953000403]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2006-12-21

NDC 61953-0004-9 [61953000409]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-11-14

NDC 61953-0004-1 [61953000401]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2006-12-21

NDC 61953-0004-0 [61953000400]

Flebogamma DIF INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125077
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-11-14

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	.05 g/mL

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
61953-0005	FLEBOGAMMA DIF	IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
61953-0004	Flebogamma	Immune Globulin (Human)
13533-335	GamaSTAN	immune globulin (human)
13533-635	GAMASTAN	IMMUNE GLOBULIN (HUMAN)
76125-900	GAMMAKED	Immune Globulin (Human)
13533-800	Gamunex-C	Immune Globulin (Human)