Mirtazapine
- Product NDC
- 71335-2978
- 11-digit product format
- 713352978
- Labeler code
- 71335
- Product ID
- 71335-2978_ef1162d6-ffa1-45b2-8c20-cd1faa11163d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077376
- Marketing category
- ANDA
- Marketing start
- 2005-12-08
- Substance
- MIRTAZAPINE
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2978_ef1162d6-ffa1-45b2-8c20-cd1faa11163d
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Mirtazapine
- Generic name
- Mirtazapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing start
- 2005-12-08
- Marketing category
- ANDA
- Application number
- ANDA077376
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| MIRTAZAPINE | 30 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 283407 |
| Spl Set Id | f86f1175-806f-4416-af86-b1e28def8244 |
| Manufacturer Name | Bryant Ranch Prepack |
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 |
|---|
| 71335-2978-1 | 71335297801 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2978-1) | 2025-11-06 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | Bryant Ranch Prepack | 2025-11-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |