NDC 13533-631

HYPERRHO S/D FULL DOSE

Rho(d) Immune Globulin (human)

HYPERRHO S/D FULL DOSE is a Intramuscular Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Rho(d) Immune Globulin.

• Product ID: 13533-631_1a029b7c-2c53-4fa0-babb-38fca3558d0b
• NDC: 13533-631
• Product Type: Plasma Derivative
• Proprietary Name: HYPERRHO S/D FULL DOSE
• Generic Name: Rho(d) Immune Globulin (human)
• Dosage Form: Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 1996-08-14
• Marketing Category: BLA / BLA
• Application Number: BLA101141
• Labeler Name: GRIFOLS USA, LLC
• Substance Name: HUMAN RHO(D) IMMUNE GLOBULIN
• Active Ingredient Strength: 1500 [iU]/1
• Pharm Classes: Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 13533-631-02

1 SYRINGE in 1 CARTON (13533-631-02) > 1 SOLUTION in 1 SYRINGE (13533-631-20)

• Marketing Start Date: 1996-08-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13533-631-02 [13533063102]

HYPERRHO S/D FULL DOSE SOLUTION

• Marketing Category: BLA
• Application Number: BLA101141
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 1996-08-14

NDC 13533-631-11 [13533063111]

HYPERRHO S/D FULL DOSE SOLUTION

• Marketing Category: BLA
• Application Number: BLA101141
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2018-04-17

NDC 13533-631-20 [13533063120]

HYPERRHO S/D FULL DOSE SOLUTION

• Marketing Category: BLA
• Application Number: BLA101141
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2012-12-01

NDC 13533-631-10 [13533063110]

HYPERRHO S/D FULL DOSE SOLUTION

• Marketing Category: BLA
• Application Number: BLA101141
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2014-09-26

NDC 13533-631-03 [13533063103]

HYPERRHO S/D FULL DOSE SOLUTION

• Marketing Category: BLA
• Application Number: BLA101141
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2018-04-17

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN RHO(D) IMMUNE GLOBULIN	1500 [iU]/1

Pharmacological Class

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

NDC Crossover Matching brand name "HYPERRHO S/D FULL DOSE" or generic name "Rho(d) Immune Globulin (human)"

NDC	Brand Name	Generic Name
13533-631	HYPERRHO	RHO(D) IMMUNE GLOBULIN (HUMAN)
13533-661	HYPERRHO	RHO(D) IMMUNE GLOBULIN (HUMAN)