Mirtazapine
- Product NDC
- 72189-626
- 11-digit product format
- 721890626
- Labeler code
- 72189
- Product ID
- 72189-626_3699b988-6d9b-dcc1-e063-6394a90ab38d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- 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
- 72189-626_3699b988-6d9b-dcc1-e063-6394a90ab38d
- SPL ID
- 3699b988-6d9b-dcc1-e063-6394a90ab38d
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Mirtazapine
- Generic name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2025-06-02
- Marketing category
- ANDA
- Application number
- ANDA076921
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| MIRTAZAPINE | 30 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 314111 |
| Spl Set Id | 3699b988-6d9a-dcc1-e063-6394a90ab38d |
| Manufacturer Name | Direct_Rx |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 72189-626-30 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-626-30) | 2025-06-02 | No |
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 |
|---|
| 72189-626-30 | 72189062630 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-626-30) | 2025-06-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | Direct_Rx | 2025-06-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |