Mirtazapine
- Product NDC
- 70954-830
- 11-digit product format
- 709540830
- Labeler code
- 70954
- Product ID
- 70954-830_2e513b1e-938d-44be-a6d9-9f22428aee8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA219919
- Marketing category
- ANDA
- Marketing start
- 2026-05-14
- Substance
- MIRTAZAPINE
- Active strength
- 7.5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|
| 70954-830-10 | 70954083010 | 30 TABLET, FILM COATED in 1 BOTTLE (70954-830-10) | 2026-05-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | ANI Pharmaceuticals, Inc. | 2026-05-20 | Human Prescription Drug Label | 3 |