Prescription drug · NDA
Imcivree (Setmelanotide) NDC 72829-010
Setmelanotide 10 mg/mL · Solution · Subcutaneous · Rhythm Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72829-010-01 | 72829001001 | 1 VIAL, MULTI-DOSE in 1 CARTON (72829-010-01) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 14, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Imcivree
- Generic name (nonproprietary)
- setmelanotide
- Active ingredients
- Setmelanotide — 10 mg/mL
- Dosage form
- Solution
- Route
- Subcutaneous
- Labeler
- Rhythm Pharmaceuticals, IncNDC labeler code 72829
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213793
- Marketing start
- Listing expires
- Other FDA classes
- Melanocortin 4 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72829-010_4e69249c-b81d-8559-e063-6294a90adbc2SPL ID 4e69249c-b81d-8559-e063-6294a90adbc2SPL set ID 70c3ccf7-4df0-4c75-ba07-fede9970c8d9RxCUI 2469346, 2469351UNII N7T15V1FUY
- Pharmacologic class
- Melanocortin 4 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
N472829001001followed by a unit qualifier and the quantityPackage 72829-0010-01. 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)
IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged [ see Dosage and Administration (2.1) ]: 4 years and older with acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic obesity due to: o Bardet-Biedl syndrome (BBS) o Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). IMCIVREE is a melanocortin 4 (MC4) receptor agonist indicated to reduce excess body …
Excerpt only. Read the full label for complete information.
About NDC 72829-010
- What is NDC 72829-010?
- 72829-010 is the product NDC for Imcivree (setmelanotide), Setmelanotide 10 mg/mL solution, listed with the FDA by Rhythm Pharmaceuticals, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imcivree (Setmelanotide).
- What is the active ingredient?
- Setmelanotide.
- Who is the labeler?
- Rhythm Pharmaceuticals, Inc, NDC labeler code 72829. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imcivree?
- 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.