Mirtazapine
- Product NDC
- 0378-3545
- 11-digit product format
- 003783545
- Labeler code
- 0378
- Product ID
- 0378-3545_681d9ec4-046b-4c0e-b85f-2468620c724b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076122
- Marketing category
- ANDA
- Marketing start
- 2003-06-20
- 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 |
|---|
| 0378-3545-01 | Mirtazapine | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 20 |
| 0378-3545-05 | Mirtazapine | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 20 |
| 0378-3545-70 | Mirtazapine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 20 |
| 0378-3545-93 | Mirtazapine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-3545 | MIRTAZAPINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 20 | Current NDC, Legacy NDC, 4 package rows | 20221019_711aa80b-8fc6-49e6-9494-3db31d9b53a4.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 |
|---|
| 0378-3545-01 | 00378354501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-01) | 2016-08-02 | 0000-00-00 | No | No | Current |
| 0378-3545-05 | 00378354505 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-05) | 2003-06-20 | 0000-00-00 | No | No | Current |
| 0378-3545-70 | 00378354570 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-70) | 2003-06-20 | 2022-03-31 | No | No | Current |
| 0378-3545-93 | 00378354593 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-93) | 2003-06-20 | 0000-00-00 | No | No | Current |