Mirtazapine
- Product NDC
- 70518-4322
- 11-digit product format
- 705184322
- Labeler code
- 70518
- Product ID
- 70518-4322_402edcd0-e3d3-bf53-e063-6294a90a7076
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076122
- Marketing category
- ANDA
- Marketing start
- 2025-03-28
- 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 |
|---|
| 70518-4322-0 | Mirtazapine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4322 | MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250330_412abf0e-1f96-4d4d-bb56-a23d4699b14c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4322-0 | 70518432200 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4322-0) | 2025-03-28 | No | No | Historical |