Mirtazapine
- Product NDC
- 70518-2453
- 11-digit product format
- 705182453
- Labeler code
- 70518
- Product ID
- 70518-2453_4a28cf77-a03a-0bf2-e063-6394a90acb34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2019-11-25
- Substance
- MIRTAZAPINE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirtazapine
- Listing expiration
- 2027-12-31
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 |
|---|
| 70518-2453-0 | Mirtazapine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 12 |
| 70518-2453-1 | Mirtazapine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2453 | MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250316_f54718d1-3ef7-4472-9e97-90e5fd30db4d.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 |
|---|
| 70518-2453-0 | 70518245300 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2453-0) | 2019-11-25 | 0000-00-00 | No | No | Current |
| 70518-2453-1 | 70518245301 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2453-1) | 2020-11-04 | 0000-00-00 | No | No | Current |