Macrilen
- Product NDC
- 71090-002
- 11-digit product format
- 710900002
- Labeler code
- 71090
- Product ID
- 71090-002_a17c00fc-7be7-423d-930d-46b152e64224
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Macimorelin acetate
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- Strongbridge U.S. Inc
- Application
- NDA205598
- Marketing category
- NDA
- Marketing start
- 2018-01-29
- Marketing end
- 0000-00-00
- 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
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71090-002-02 | 71090000202 | 1 POUCH in 1 CARTON (71090-002-02) > 60 mg in 1 POUCH | 1 pouch | 2018-01-29 | 0000-00-00 | No | No | Current |