Mirtazapine
- Product NDC
- 43353-378
- 11-digit product format
- 433530378
- Labeler code
- 43353
- Product ID
- 43353-378_1bf61730-9fb6-49cb-e063-6394a90a3b21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077666
- Marketing category
- ANDA
- Marketing start
- 2007-08-22
- 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 |
|---|
| 43353-378-15 | Mirtazapine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
| 43353-378-30 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 43353-378-45 | Mirtazapine | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 3 |
| 43353-378-60 | Mirtazapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-378 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240630_ac976282-fb68-4db0-912a-28f075b0716c.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 |
|---|
| 43353-378-15 | 43353037815 | 15 TABLET, FILM COATED in 1 BOTTLE (43353-378-15) | 2018-08-10 | 0000-00-00 | No | No | Current |
| 43353-378-30 | 43353037830 | 30 TABLET, FILM COATED in 1 BOTTLE (43353-378-30) | 2018-08-10 | 0000-00-00 | No | No | Current |
| 43353-378-45 | 43353037845 | 45 TABLET, FILM COATED in 1 BOTTLE (43353-378-45) | 2018-08-10 | 0000-00-00 | No | No | Current |
| 43353-378-53 | 43353037853 | 60 TABLET, FILM COATED in 1 BOTTLE (43353-378-53) | 2018-08-10 | 0000-00-00 | No | No | Current |
| 43353-378-60 | 43353037860 | 90 TABLET, FILM COATED in 1 BOTTLE (43353-378-60) | 2024-06-28 | | No | No | Current |