Mirtazapine
- Product NDC
- 55154-8335
- 11-digit product format
- 551548335
- Labeler code
- 55154
- Product ID
- 55154-8335_8c99c382-530d-428d-8172-710b3ab71e83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA077376
- Marketing category
- ANDA
- Marketing start
- 2005-12-08
- Substance
- MIRTAZAPINE
- Active strength
- 15 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 283406 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-8335-6 | Mirtazapine | 1 in 1 BAG | TABLET, ORALLY DISINTEGRATING | 1 | | 6 |
| 55154-8335-6 | Mirtazapine | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-8335 | MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH 107, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240928_5127517f-b8d0-4af1-8a2f-5225719600bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-8335-6 | 55154833506 | 1 BLISTER PACK in 1 BAG (55154-8335-6) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2005-12-08 | 0000-00-00 | No | No | Current |