NDC 44206-300

Rhophylac

Human Rho(d) Immune Globulin

Rhophylac is a Intramuscular; Intravenous Solution in the Plasma Derivative category. It is labeled and distributed by Csl Behring Ag. The primary component is Human Rho(d) Immune Globulin.

• Product ID: 44206-300_03b4c36d-5ef7-4ce4-ad3d-d375a1347905
• NDC: 44206-300
• Product Type: Plasma Derivative
• Proprietary Name: Rhophylac
• Generic Name: Human Rho(d) Immune Globulin
• Dosage Form: Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2009-01-06
• Marketing Category: BLA / BLA
• Application Number: BLA125070
• Labeler Name: CSL Behring AG
• Substance Name: HUMAN RHO(D) IMMUNE GLOBULIN
• Active Ingredient Strength: 1500 [iU]/2mL
• Pharm Classes: Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 44206-300-01

1 SYRINGE, GLASS in 1 CARTON (44206-300-01) > 2 mL in 1 SYRINGE, GLASS (44206-300-90)

• Marketing Start Date: 2009-01-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44206-300-01 [44206030001]

RHOPHYLAC SOLUTION

• Marketing Category: BLA
• Application Number: BLA125070
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2009-01-06

NDC 44206-300-90 [44206030090]

RHOPHYLAC SOLUTION

• Marketing Category: BLA
• Application Number: BLA125070
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2012-09-11

NDC 44206-300-10 [44206030010]

RHOPHYLAC SOLUTION

• Marketing Category: BLA
• Application Number: BLA125070
• Product Type: PLASMA DERIVATIVE
• Billing Unit: ML
• Marketing Start Date: 2009-01-06

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN RHO(D) IMMUNE GLOBULIN	1500 [iU]/2mL

Pharmacological Class

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

NDC Crossover Matching brand name "Rhophylac" or generic name "Human Rho(d) Immune Globulin"

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