Mirtazapine
- Product NDC
- 72603-558
- 11-digit product format
- 726030558
- Labeler code
- 72603
- Product ID
- 72603-558_979eec8b-1bf4-466b-812e-85a111ce1cb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2025-04-01
- Substance
- MIRTAZAPINE
- Active strength
- 7.5 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 |
|---|
| 72603-558-01 | 72603055801 | 30 TABLET, FILM COATED in 1 BOTTLE (72603-558-01) | 2025-04-01 | No | No | Historical |
| 72603-558-02 | 72603055802 | 500 TABLET, FILM COATED in 1 BOTTLE (72603-558-02) | 2025-04-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | NorthStar Rx LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2025-02-24 | Human Prescription Drug Label | 1 |