Mirtazapine
- Product NDC
- 71610-713
- 11-digit product format
- 716100713
- Labeler code
- 71610
- Product ID
- 71610-713_f2e7c35d-7c1f-47c3-9879-0ab71aa7a869
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076541
- Marketing category
- ANDA
- Marketing start
- 2004-04-22
- Substance
- MIRTAZAPINE
- Active strength
- 30 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-713-15 | 71610071315 | 15 TABLET in 1 BOTTLE (71610-713-15) | 15 tablet | 2023-06-05 | No | No | Historical |
| 71610-713-45 | 71610071345 | 45 TABLET in 1 BOTTLE (71610-713-45) | 45 tablet | 2023-06-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | 2023-06-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |