Mirtazapine
- Product NDC
- 70954-830
- 11-digit product format
- 709540830
- Labeler code
- 70954
- Product ID
- 70954-830_2e513b1e-938d-44be-a6d9-9f22428aee8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA219919
- Marketing category
- ANDA
- Marketing start
- 2026-05-14
- Substance
- MIRTAZAPINE
- Active strength
- 7.5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirtazapine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRTAZAPINE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 311725, 311726, 314111, 476809 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-830-10 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-830-10 | 70954083010 | 30 TABLET, FILM COATED in 1 BOTTLE (70954-830-10) | 2026-05-14 | No | No | Current |