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NDC 50484-0810-15 REGRANEX 100 ug/g Details
REGRANEX 100 ug/g
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.
MedlinePlus Drug Summary
Becaplermin gel is used as part of a total treatment program to help heal certain ulcers (sores) of the foot, ankle, or leg in people who have diabetes. Becaplermin gel must be used along with good ulcer care including: removal of dead tissue by a medical professional; the use of special shoes, walkers, crutches, or wheelchairs to keep weight off the ulcer; and treatment of any infections that develop. Becaplermin cannot be used to treat ulcers that have been stitched or stapled. Becaplermin is a human platelet-derived growth factor, a substance naturally produced by the body that helps in wound healing. It works by helping to repair and replace dead skin and other tissues, attracting cells that repair wounds, and helping to close and heal the ulcer.
Related Packages: 50484-0810-15Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Becaplermin Topical
Product Information
| NDC | 50484-0810 |
|---|---|
| Product ID | 50484-810_0c3fee4a-499b-49ec-e063-6394a90ac276 |
| Associated GPIs | 90945020004020 |
| GCN Sequence Number | 037223 |
| GCN Sequence Number Description | becaplermin GEL (GRAM) 0.01 % TOPICAL |
| HIC3 | L0C |
| HIC3 Description | DIABETIC ULCER PREPARATIONS,TOPICAL |
| GCN | 54561 |
| HICL Sequence Number | 017028 |
| HICL Sequence Number Description | BECAPLERMIN |
| Brand/Generic | Brand |
| Proprietary Name | REGRANEX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | becaplermin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | ug/g |
| Substance Name | BECAPLERMIN |
| Labeler Name | Smith & Nephew, Inc. |
| Pharmaceutical Class | Human Platelet-derived Growth Factor [EPC], Platelet-Derived Growth Factor [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103691 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50484-0810-15 (50484081015)
| NDC Package Code | 50484-810-15 |
|---|---|
| Billing NDC | 50484081015 |
| Package | 1 TUBE in 1 CARTON (50484-810-15) / 15 g in 1 TUBE |
| Marketing Start Date | 2014-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |