NDC 57894-200

REOPRO

Abciximab

REOPRO is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Abciximab.

• Product ID: 57894-200_445024d0-7ea4-11e8-805e-1c8b9d46d017
• NDC: 57894-200
• Product Type: Human Prescription Drug
• Proprietary Name: REOPRO
• Generic Name: Abciximab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-01-03
• Marketing Category: BLA / BLA
• Application Number: BLA103575
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: ABCIXIMAB
• Active Ingredient Strength: 2 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57894-200-01

1 VIAL, SINGLE-USE in 1 BOX (57894-200-01) > 5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2017-01-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-200-01 [57894020001]

REOPRO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103575
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-01-03
• Marketing End Date: 2019-09-30

Drug Details

Active Ingredients

Ingredient	Strength
ABCIXIMAB	2 mg/mL

OpenFDA Data

• SPL SET ID: a5cf75d2-322e-4767-9204-4aaa0889d7db
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • X85G7936GV
• RxNorm Concept Unique ID - RxCUI:
  • 108911
  • 241162