Prescription drug · NDA
Vyleesi (Bremelanotide) NDC 0713-0897
Bremelanotide acetate 1.75 mg/.3mL · Injection · Subcutaneous · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0897-04 | 0071308970400713089704 | 4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06)Marketed from Nov 12, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vyleesi
- Generic name (nonproprietary)
- bremelanotide
- Active ingredients
- Bremelanotide acetate — 1.75 mg/.3mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210557
- Marketing start
- Listing expires
- Other FDA classes
- Melanocortin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0713-0897_437e6c45-dfb9-35ec-e063-6394a90a7874SPL ID 437e6c45-dfb9-35ec-e063-6394a90a7874SPL set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcfRxCUI 2176316, 2176321UNII PV2WI7495P
- Pharmacologic class
- Melanocortin Receptor Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400713089704followed by a unit qualifier and the quantityPackage 00713-0897-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of Use VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI i…
Excerpt only. Read the full label for complete information.
About NDC 0713-0897
- What is NDC 0713-0897?
- 0713-0897 is the product NDC for Vyleesi (bremelanotide), Bremelanotide acetate 1.75 mg/.3mL injection, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vyleesi (Bremelanotide).
- What is the active ingredient?
- Bremelanotide acetate.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vyleesi?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.