Imcivree
- Product NDC
- 72829-010
- 11-digit product format
- 728290010
- Labeler code
- 72829
- Product ID
- 72829-010_4e69249c-b81d-8559-e063-6294a90adbc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- setmelanotide
- Dosage form
- SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Rhythm Pharmaceuticals, Inc
- Application
- NDA213793
- Marketing category
- NDA
- Marketing start
- 2020-12-14
- Substance
- SETMELANOTIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Melanocortin 4 Receptor Agonist [EPC], Melanocortin 4 Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Imcivree
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SETMELANOTIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7T15V1FUY |
| Rxcui | 2469346, 2469351 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 72829-010-01 | 2025-05-16 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
| 72829-010-01 | 2025-05-16 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
| 72829-010-01 | 2025-01-30 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
| 72829-010-01 | 2025-01-30 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
| 72829-010-01 | 2022-04-11 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
| 72829-010-01 | 2022-04-11 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
| 72829-010-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
| 72829-010-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6750-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use IMCIVREE safely and effectively. See full prescribing information for IMCIVREE. IMCIVREE® (setmelanotide) injection, for subcutaneous use Initial U.S. Approval: 2020 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72829-010-01 | Imcivree | 1 mL in 1 VIAL, MULTI-DOSE | SOLUTION | 1 | | 14 |
| 72829-010-01 | Imcivree | 1 in 1 CARTON | SOLUTION | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72829-010 | IMCIVREE (SETMELANOTIDE) SOLUTION [RHYTHM PHARMACEUTICALS, INC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250523_70c3ccf7-4df0-4c75-ba07-fede9970c8d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72829-010-01 | 72829001001 | 1 VIAL, MULTI-DOSE in 1 CARTON (72829-010-01) / 1 mL in 1 VIAL, MULTI-DOSE | 2020-12-14 | 0000-00-00 | No | No | Current |