Macrilen
- Product NDC
- 0169-1401
- 11-digit product format
- 001691401
- Labeler code
- 0169
- Product ID
- 0169-1401_ed003972-d498-43fc-b809-05a47d86b8da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Macimorelin acetate
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- Novo Nordisk
- Application
- NDA205598
- Marketing category
- NDA
- Marketing start
- 2022-01-31
- Marketing end
- 2027-02-28
- Substance
- MACIMORELIN
- Active strength
- 60 mg/mg
- Pharmacologic classes
- Growth Hormone Secretagogue Receptor Agonist [EPC], Growth Hormone Secretagogue Receptor Agonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Macrilen
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MACIMORELIN | 60 mg/mg |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8680B21W73 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-1401-01 | Macrilen | 1 in 1 CARTON | GRANULE, FOR SOLUTION | 1 | | 7 |
| 0169-1401-01 | Macrilen | 60 mg in 1 POUCH | GRANULE, FOR SOLUTION | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-1401 | MACRILEN (MACIMORELIN ACETATE) GRANULE, FOR SOLUTION [NOVO NORDISK] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241220_6034c9b8-5a36-4961-a5dd-11ebf7bdab78.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0169-1401-01 | 00169140101 | 1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH | 1 pouch | 2022-01-31 | 2027-02-28 | No | No | Current |