NDC 0562-7805

RhoGAM Ultra-Filtered PLUS

Human Rho(d) Immune Globulin

RhoGAM Ultra-Filtered PLUS is a Intramuscular Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Kedrion Melville Inc.. The primary component is Human Rho(d) Immune Globulin.

• Product ID: 0562-7805_5524e781-b067-4334-924f-c2b8ec11803d
• NDC: 0562-7805
• Product Type: Plasma Derivative
• Proprietary Name: RhoGAM Ultra-Filtered PLUS
• Generic Name: Human Rho(d) Immune Globulin
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2007-03-09
• Marketing Category: BLA / BLA
• Application Number: BLA103777
• Labeler Name: Kedrion Melville Inc.
• Substance Name: HUMAN RHO(D) IMMUNE GLOBULIN
• Active Ingredient Strength: 300 ug/1
• Pharm Classes: Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0562-7805-01

1 POUCH in 1 CARTON (0562-7805-01) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)

• Marketing Start Date: 2007-03-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0562-7805-25 [00562780525]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103777
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2007-03-09

NDC 0562-7805-00 [00562780500]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103777
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2012-07-10

NDC 0562-7805-05 [00562780505]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103777
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2007-03-09

NDC 0562-7805-01 [00562780501]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103777
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2007-03-09

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN RHO(D) IMMUNE GLOBULIN	300 ug/1

Pharmacological Class

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

NDC Crossover Matching brand name "RhoGAM Ultra-Filtered PLUS" or generic name "Human Rho(d) Immune Globulin"

NDC	Brand Name	Generic Name
0562-7805	RhoGAM Ultra-Filtered PLUS	HUMAN RHO(D) IMMUNE GLOBULIN
0562-7806	MICRhoGAM Ultra-Filtered PLUS	HUMAN RHO(D) IMMUNE GLOBULIN
44206-300	Rhophylac	HUMAN RHO(D) IMMUNE GLOBULIN