NDC 70257-310

WinRho SDF

Rho (d) Immune Globulin

WinRho SDF is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Saol Therapeutics Inc.. The primary component is Human Rho(d) Immune Globulin.

• Product ID: 70257-310_40b487d4-5658-437b-99de-c0130d5d6bbb
• NDC: 70257-310
• Product Type: Human Prescription Drug
• Proprietary Name: WinRho SDF
• Generic Name: Rho (d) Immune Globulin
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2019-03-01
• Marketing Category: BLA / BLA
• Application Number: BLA103649
• Labeler Name: Saol Therapeutics Inc.
• Substance Name: HUMAN RHO(D) IMMUNE GLOBULIN
• Active Ingredient Strength: 5000 [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: 2021-12-31

Packaging

NDC 70257-310-51

1 VIAL, SINGLE-DOSE in 1 CARTON (70257-310-51) > 1 INJECTION in 1 VIAL, SINGLE-DOSE (70257-310-04)

• Marketing Start Date: 2019-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70257-310-04 [70257031004]

WinRho SDF INJECTION

• Marketing Category: BLA
• Application Number: BLA103649
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-01

NDC 70257-310-51 [70257031051]

WinRho SDF INJECTION

• Marketing Category: BLA
• Application Number: BLA103649
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-01

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	5000 [iU]/1

OpenFDA Data

• SPL SET ID: b8809e8b-9a6f-47d3-80de-fe46ae79f7cd
• Manufacturer:
  • Saol Therapeutics Inc.
• 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 SDF" or generic name "Rho (d) Immune Globulin"

NDC	Brand Name	Generic Name
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
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