Mirtazapine
- Product NDC
- 71610-717
- 11-digit product format
- 716100717
- Labeler code
- 71610
- Product ID
- 71610-717_4092fb19-ff2d-4329-aa77-bcc947c6a1a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077666
- Marketing category
- ANDA
- Marketing start
- 2007-08-22
- Substance
- MIRTAZAPINE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| A051Q2099Q | MIRTAZAPINE | 85650-52-8 | MIRTAZAPINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-717-15 | 71610071715 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-717-15) | 2023-06-19 | No | No | Historical |
| 71610-717-60 | 71610071760 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-717-60) | 2023-06-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | 2023-06-29 | HUMAN PRESCRIPTION DRUG LABEL | 3 |