Mirtazapine
- Product NDC
- 63187-471
- 11-digit product format
- 631870471
- Labeler code
- 63187
- Product ID
- 63187-471_fb4bf3e5-f62b-489a-ba75-8e94513f29ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-471-30 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 63187-471-60 | Mirtazapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 63187-471-90 | Mirtazapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-471 | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20221020_3b516a33-b164-4e4f-bc18-e9d1e591323a.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 |
|---|
| 63187-471-30 | 63187047130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-471-30) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-471-60 | 63187047160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-471-60) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-471-90 | 63187047190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-471-90) | 2015-02-02 | 0000-00-00 | No | No | Current |