Regranex Gel 0.01%
- Product NDC
- 85822-734
- 11-digit product format
- 858220734
- Labeler code
- 85822
- Product ID
- 85822-734_a76b93e5-1b94-4a52-8efc-52c09c797ed6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Becaplermin gel 0.01%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- LRM Therapeutics, LLC
- Application
- BLA103691
- Marketing category
- BLA
- Marketing start
- 2025-06-13
- Substance
- BECAPLERMIN
- Active strength
- .1 mg/g
- Pharmacologic classes
- Human Platelet-derived Growth Factor [EPC], Platelet-Derived Growth Factor [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Regranex Gel 0.01%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BECAPLERMIN | .1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1B56C968OA |
| Rxcui | 213197, 308579 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85822-734-15 | Regranex Gel 0.01% | 15 g in 1 TUBE | GEL | 15 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85822-734-15 | 85822073415 | 15 g in 1 TUBE (85822-734-15) | 15 g | 2025-06-30 | No | No | Historical |