Myalept
- Product NDC
- 76431-210
- 11-digit product format
- 764310210
- Labeler code
- 76431
- Product ID
- 76431-210_d02c8a27-7501-4b03-bf87-43f4948f11a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metreleptin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amryt Pharmaceuticals DAC
- Application
- BLA125390
- Marketing category
- BLA
- Marketing start
- 2015-03-05
- Marketing end
- 0000-00-00
- Substance
- METRELEPTIN
- Active strength
- 11 mg/2.2mL
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], Leptin Analog [EPC], Leptin [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Metreleptin | ACTIVE INGREDIENT | TL60C27RLH | MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.] | 4 | |
| Metreleptin | ACTIVE MOIETY | TL60C27RLH | MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.] | 4 | |
| Glutamic Acid | INACTIVE INGREDIENT | 3KX376GY7L | MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.] | 4 | |
| Glycine | INACTIVE INGREDIENT | TE7660XO1C | MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.] | 4 | |
| Polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.] | 4 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76431-210 | MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMRYT PHARMACEUTICALS DESIGNATED ACTIVITY COMPANY] | 14 | Legacy NDC | 20250228_c986f93b-855d-4ef0-b620-5d41a0513e48.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76431-210-01 | 76431021001 | 1 VIAL, GLASS in 1 CARTON (76431-210-01) > 2.2 mL in 1 VIAL, GLASS | 2015-03-05 | 0000-00-00 | No | No | Current |