NDC 70504-3500

WINRHO

Rho (d) Immune Globulin

WINRHO is a Intramuscular; Intravenous Liquid in the Human Prescription Drug category. It is labeled and distributed by Aptevo Biotherapeutics Llc. The primary component is Human Rho(d) Immune Globulin.

• Product ID: 70504-3500_af5a44ab-5033-43c7-a3a4-eade9010bcbb
• NDC: 70504-3500
• Product Type: Human Prescription Drug
• Proprietary Name: WINRHO
• Generic Name: Rho (d) Immune Globulin
• Dosage Form: Liquid
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2016-07-01
• Marketing Category: BLA / BLA
• Application Number: BLA103649
• Labeler Name: Aptevo BioTherapeutics LLC
• Substance Name: HUMAN RHO(D) IMMUNE GLOBULIN
• Active Ingredient Strength: 2500 [iU]/mL
• 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 70504-3500-2

1 VIAL, SINGLE-DOSE in 1 CARTON (70504-3500-2) > 2.2 mL in 1 VIAL, SINGLE-DOSE (70504-3500-1)

• Marketing Start Date: 2016-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70504-3500-2 [70504350002]

WINRHO LIQUID

• Marketing Category: BLA
• Application Number: BLA103649
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-07-01

NDC 70504-3500-1 [70504350001]

WINRHO LIQUID

• Marketing Category: BLA
• Application Number: BLA103649
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-07-01

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	2500 [iU]/mL

OpenFDA Data

• SPL SET ID: c0948763-cfc2-49fc-86b0-76abcf036f70
• Manufacturer:
  • Aptevo BioTherapeutics LLC
• UNII:
  • 66Y330CJHS
• RxNorm Concept Unique ID - RxCUI:
  • 1790383
  • 1790382
  • 1790374
  • 1790506
  • 1790508
  • 1790379
  • 1790512
  • 1790513

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
70504-3000	WINRHO	rho (d) immune globulin
70504-3100	WINRHO	rho (d) immune globulin
70504-3300	WINRHO	rho (d) immune globulin
70504-3500	WINRHO	rho (d) immune globulin
70257-300	WinRho SDF	rho (d) immune globulin
70257-310	WinRho SDF	rho (d) immune globulin
70257-330	WinRho SDF	rho (d) immune globulin
70257-350	WinRho SDF	rho (d) immune globulin