Mirtazapine
- Product NDC
- 60505-0249
- 11-digit product format
- 605050249
- Labeler code
- 60505
- Product ID
- 60505-0249_c076cd92-b06d-b317-cc04-6f99b3718cf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA077666
- Marketing category
- ANDA
- Marketing start
- 2007-08-22
- Substance
- MIRTAZAPINE
- Active strength
- 45 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 | 45 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 311725, 311726, 314111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-0249-1 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 20 |
| 60505-0249-3 | Mirtazapine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 20 |
| 60505-0249-5 | Mirtazapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 20 |
| 60505-0249-8 | Mirtazapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0249 | MIRTAZAPINE TABLET, FILM COATED [APOTEX CORP.] | 19 | Current NDC, Legacy NDC, 4 package rows | 20241105_9675333e-3064-c8cb-a4b4-6c74d9a82f17.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 |
|---|
| 60505-0249-1 | 60505024901 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-0249-1) | 2007-08-22 | 0000-00-00 | No | No | Current |
| 60505-0249-3 | 60505024903 | 100 TABLET, FILM COATED in 1 BOTTLE (60505-0249-3) | 2007-08-22 | 0000-00-00 | No | No | Current |
| 60505-0249-5 | 60505024905 | 500 TABLET, FILM COATED in 1 BOTTLE (60505-0249-5) | 2007-08-22 | 0000-00-00 | No | No | Current |
| 60505-0249-8 | 60505024908 | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0249-8) | 2007-08-22 | 0000-00-00 | No | No | Current |