Mirtazapine
- Product NDC
- 71335-1055
- 11-digit product format
- 713351055
- Labeler code
- 71335
- Product ID
- 71335-1055_0fb483ad-a071-4c42-a861-495690277779
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2004-10-22
- 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 | 311725 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1055-1 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 103 |
| 71335-1055-2 | Mirtazapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 103 |
| 71335-1055-3 | Mirtazapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 103 |
| 71335-1055-4 | Mirtazapine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 103 |
| 71335-1055-5 | Mirtazapine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 103 |
| 71335-1055-6 | Mirtazapine | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 103 |
| 71335-1055-7 | Mirtazapine | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 103 |
| 71335-1055-8 | Mirtazapine | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1055 | MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 8 package rows | 20240406_1cc1a159-11ec-4040-817b-d57fa827a773.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 |
|---|
| 71335-1055-1 | 71335105501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1055-1) | 2019-01-10 | 0000-00-00 | No | No | Current |
| 71335-1055-2 | 71335105502 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1055-2) | 2022-12-01 | 0000-00-00 | No | No | Current |
| 71335-1055-3 | 71335105503 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1055-3) | 2024-04-02 | 0000-00-00 | No | No | Current |
| 71335-1055-4 | 71335105504 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1055-4) | 2024-04-02 | 0000-00-00 | No | No | Current |
| 71335-1055-5 | 71335105505 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1055-5) | 2024-04-02 | 0000-00-00 | No | No | Current |
| 71335-1055-6 | 71335105506 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1055-6) | 2024-04-02 | 0000-00-00 | No | No | Current |
| 71335-1055-7 | 71335105507 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1055-7) | 2024-04-02 | 0000-00-00 | No | No | Current |
| 71335-1055-8 | 71335105508 | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1055-8) | 2024-04-02 | 0000-00-00 | No | No | Current |