Mirtazapine
- Product NDC
- 42291-494
- 11-digit product format
- 422910494
- Labeler code
- 42291
- Product ID
- 42291-494_3f7cebc7-2ea8-12e2-e063-6394a90abdc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA076541
- Marketing category
- ANDA
- Marketing start
- 2022-08-02
- Substance
- MIRTAZAPINE
- Active strength
- 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 476809 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-494-30 | Mirtazapine | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 42291-494-90 | Mirtazapine | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-494 | MIRTAZAPINE TABLET [AVKARE] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240110_e5478a6a-a29a-9f61-e053-2995a90a11d0.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 |
|---|
| 42291-494-30 | 42291049430 | 30 TABLET in 1 BOTTLE (42291-494-30) | 30 tablet | 2022-08-02 | 0000-00-00 | No | No | Current |
| 42291-494-90 | 42291049490 | 90 TABLET in 1 BOTTLE (42291-494-90) | 90 tablet | 2025-09-23 | | No | No | Current |