NDC 50484-810

REGRANEX

Becaplermin

REGRANEX is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Smith & Nephew, Inc.. The primary component is Becaplermin.

• Product ID: 50484-810_46097979-193c-4294-bd44-d08b8d493897
• NDC: 50484-810
• Product Type: Human Prescription Drug
• Proprietary Name: REGRANEX
• Generic Name: Becaplermin
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-11-01
• Marketing Category: BLA / BLA
• Application Number: BLA103691
• Labeler Name: Smith & Nephew, Inc.
• Substance Name: BECAPLERMIN
• Active Ingredient Strength: 100 ug/g
• Pharm Classes: Human Platelet-derived Growth Factor [EPC],Platelet-Derived Growth Factor [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50484-810-15

1 TUBE in 1 CARTON (50484-810-15) > 15 g in 1 TUBE

• Marketing Start Date: 2014-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50484-810-15 [50484081015]

REGRANEX GEL

• Marketing Category: BLA
• Application Number: BLA103691
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-08-01

Drug Details

Active Ingredients

Ingredient	Strength
BECAPLERMIN	100 ug/g

OpenFDA Data

• SPL SET ID: fd2c7d21-7b07-4ab3-8983-816ab3223771
• Manufacturer:
  • Smith & Nephew, Inc.
• UNII:
  • 1B56C968OA
• RxNorm Concept Unique ID - RxCUI:
  • 213197
  • 308579
• UPC Code:
  • 0350484810153

Pharmacological Class

• Human Platelet-derived Growth Factor [EPC]
• Platelet-Derived Growth Factor [CS]

Medicade Reported Pricing

50484081015 REGRANEX 0.01% GEL

Pricing Unit: GM | Drug Type: