SCENESSE
- Product NDC
- 73372-0116
- 11-digit product format
- 733720116
- Labeler code
- 73372
- Product ID
- 73372-0116_5192f26d-d5e7-ce03-e063-6294a90a3ea2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- afamelanotide
- Dosage form
- IMPLANT
- Route
- SUBCUTANEOUS
- Labeler
- CLINUVEL INC.
- Application
- NDA210797
- Marketing category
- NDA
- Marketing start
- 2019-12-31
- Substance
- AFAMELANOTIDE
- Active strength
- 16 mg/16mg
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SCENESSE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AFAMELANOTIDE | 16 mg/16mg |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QW68W3J66U |
| Rxcui | 2262254, 2262259 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73372-0116-1 | SCENESSE | 1 mg in 1 VIAL, GLASS | IMPLANT | 1 | | 11 |
| 73372-0116-1 | SCENESSE | 1 in 1 CARTON | IMPLANT | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73372-0116 | SCENESSE (AFAMELANOTIDE) IMPLANT [CLINUVEL INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240816_94f53286-11dd-7fbb-e053-2a95a90a7c48.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 |
|---|
| 73372-0116-1 | 73372011601 | 1 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS | 2019-12-31 | 0000-00-00 | No | No | Current |