mirtazapine
- Product NDC
- 31722-408
- 11-digit product format
- 317220408
- Labeler code
- 31722
- Product ID
- 31722-408_4e8e5591-9b05-8885-e063-6394a90a02e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA219721
- Marketing category
- ANDA
- Marketing start
- 2025-10-02
- Substance
- MIRTAZAPINE
- Active strength
- 15 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 | 15 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 |
|---|
| 31722-408-05 | mirtazapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 31722-408-10 | mirtazapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 31722-408-30 | mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-408-05 | 31722040805 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-408-05) | 2025-10-02 | No | No | Historical |
| 31722-408-10 | 31722040810 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-408-10) | 2025-10-02 | No | No | Historical |
| 31722-408-30 | 31722040830 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-408-30) | 2025-10-02 | No | No | Historical |