REGRANEX
- Product NDC
- 50484-810
- 11-digit product format
- 504840810
- Labeler code
- 50484
- Product ID
- 50484-810_be6974e1-70b7-4664-9c8a-b043c2ad2604
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- becaplermin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Smith & Nephew, Inc.
- Application
- BLA103691
- Marketing category
- BLA
- Marketing start
- 2011-11-01
- Marketing end
- 0000-00-00
- Substance
- BECAPLERMIN
- Active strength
- 100 ug/g
- Pharmacologic classes
- Human Platelet-derived Growth Factor [EPC],Platelet-Derived Growth Factor [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BECAPLERMIN | ACTIVE INGREDIENT | 1B56C968OA | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| BECAPLERMIN | ACTIVE MOIETY | 1B56C968OA | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| LYSINE HYDROCHLORIDE | INACTIVE INGREDIENT | JNJ23Q2COM | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50484-810 | REGRANEX (BECAPLERMIN) GEL [SMITH & NEPHEW, INC.] | 7 | Legacy NDC | 20231212_fd2c7d21-7b07-4ab3-8983-816ab3223771.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50484-810-15 | 50484081015 | 1 TUBE in 1 CARTON (50484-810-15) > 15 g in 1 TUBE | 1 tube | 2014-08-01 | 0000-00-00 | No | No | Current |