Mirtazapine
- Product NDC
- 68788-7324
- 11-digit product format
- 687887324
- Labeler code
- 68788
- Product ID
- 68788-7324_f2bab0cb-5847-4a96-96a8-263dbdecf379
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2020-11-23
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7324-1 | Mirtazapine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 6 |
| 68788-7324-3 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 68788-7324-6 | Mirtazapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 68788-7324-9 | Mirtazapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7324 | MIRTAZAPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240720_ac3716fd-6971-4a70-ae7b-9f5117f3d880.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7324-1 | 68788732401 | 15 TABLET, FILM COATED in 1 BOTTLE (68788-7324-1) | 2020-11-23 | 0000-00-00 | No | No | Current |
| 68788-7324-3 | 68788732403 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7324-3) | 2020-11-23 | 0000-00-00 | No | No | Current |
| 68788-7324-6 | 68788732406 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7324-6) | 2020-11-23 | 0000-00-00 | No | No | Current |
| 68788-7324-9 | 68788732409 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7324-9) | 2020-11-23 | 0000-00-00 | No | No | Current |