Vyleesi
- Product NDC
- 0713-0897
- 11-digit product format
- 007130897
- Labeler code
- 0713
- Product ID
- 0713-0897_437e6c45-dfb9-35ec-e063-6394a90a7874
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bremelanotide
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- NDA210557
- Marketing category
- NDA
- Marketing start
- 2025-11-12
- Substance
- BREMELANOTIDE ACETATE
- Active strength
- 1.75 mg/.3mL
- Pharmacologic classes
- Melanocortin Receptor Agonist [EPC], Melanocortin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vyleesi
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BREMELANOTIDE ACETATE | 1.75 mg/.3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PV2WI7495P |
| Rxcui | 2176316, 2176321 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0897-04 | Vyleesi | 4 in 1 CARTON | INJECTION | 4 | | 1 |
| 0713-0897-06 | Vyleesi | 0.3 mL in 1 SYRINGE | INJECTION | 0.3 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-0897-04 | 00713089704 | 4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06) | 4 syringe | 2025-11-12 | No | No | Historical |
| 0713-0897-06 | 00713089706 | 0.3 mL in 1 SYRINGE | 0.3 ml | | | | Historical |