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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirtazapine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRTAZAPINE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 314111 |
Packages#
Package NDC, 11-digit format, Description table| 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 |