Mirtazapine
- Product NDC
- 71610-523
- 11-digit product format
- 716100523
- Labeler code
- 71610
- Product ID
- 71610-523_622e1f6b-89f8-4ade-ac9f-cebcf8d94aea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076122
- Marketing category
- ANDA
- Marketing start
- 2003-06-19
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-523-15 | 71610052315 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-15) | 2021-04-23 | No | No | Historical |
| 71610-523-30 | 71610052330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-30) | 2021-02-03 | No | No | Historical |
| 71610-523-45 | 71610052345 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-45) | 2021-04-23 | No | No | Historical |
| 71610-523-53 | 71610052353 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-53) | 2021-08-04 | No | No | Historical |
| 71610-523-60 | 71610052360 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-523-60) | 2021-02-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | 2021-08-20 | HUMAN PRESCRIPTION DRUG LABEL | 4 |