Macrilen
- Product NDC
- 58844-130
- 11-digit product format
- 588440130
- Labeler code
- 58844
- Product ID
- 58844-130_4b196948-f481-3bd6-e063-6394a90aaae1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Macimorelin acetate
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- Aeterna Zentaris GmbH
- Application
- NDA205598
- Marketing category
- NDA
- Marketing start
- 2018-01-29
- Substance
- MACIMORELIN
- Active strength
- 60 mg/1817mg
- Pharmacologic classes
- Growth Hormone Secretagogue Receptor Agonist [EPC], Growth Hormone Secretagogue 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
- Macrilen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MACIMORELIN | 60 mg/1817mg |
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 |
|---|
| 58844-130-01 | Macrilen | 60 mg in 1 POUCH | GRANULE, FOR SOLUTION | 60 | | 3 |
| 58844-130-01 | Macrilen | 1 in 1 CARTON | GRANULE, FOR SOLUTION | 1 | | 3 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58844-130-01 | 58844013001 | 1 POUCH in 1 CARTON (58844-130-01) / 60 mg in 1 POUCH | 1 pouch | 2018-01-29 | No | No | Current |