Mirtazapine
- Product NDC
- 80425-0305
- 11-digit product format
- 804250305
- Labeler code
- 80425
- Product ID
- 80425-0305_2a9ba8f4-6cee-e827-e063-6394a90a0300
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2023-04-07
- Substance
- MIRTAZAPINE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Mirtazapine
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| MIRTAZAPINE | 15 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 311725 |
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 |
|---|
| 80425-0305-1 | 80425030501 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0305-1) | 2023-04-07 | No | No | Historical |
| 80425-0305-2 | 80425030502 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0305-2) | 2023-04-07 | No | No | Historical |
| 80425-0305-3 | 80425030503 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0305-3) | 2023-04-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine HCL Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |