NDC 63459-177

SYNRIBO

Omacetaxine Mepesuccinate

SYNRIBO is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is Omacetaxine Mepesuccinate.

• Product ID: 63459-177_32221c80-ccf1-4539-b41b-b4cbede7d5e0
• NDC: 63459-177
• Product Type: Human Prescription Drug
• Proprietary Name: SYNRIBO
• Generic Name: Omacetaxine Mepesuccinate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2012-11-19
• Marketing Category: NDA / NDA
• Application Number: NDA203585
• Labeler Name: Cephalon, Inc.
• Substance Name: OMACETAXINE MEPESUCCINATE
• Active Ingredient Strength: 4 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63459-177-14

1 VIAL, SINGLE-USE in 1 CARTON (63459-177-14) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2012-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63459-177-14 [63459017714]

SYNRIBO INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA203585
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-11-19

Drug Details

Active Ingredients

Ingredient	Strength
OMACETAXINE MEPESUCCINATE	3.5 mg/mL

OpenFDA Data

• SPL SET ID: 83a504ef-cf92-467d-9ecf-d251194a3484
• Manufacturer:
  • Cephalon, Inc.
• UNII:
  • 6FG8041S5B
• RxNorm Concept Unique ID - RxCUI:
  • 1356688
  • 1356693