Mirtazapine
- Product NDC
- 48433-076
- 11-digit product format
- 484330076
- Labeler code
- 48433
- Product ID
- 48433-076_4c13278f-899f-f1b7-e063-6394a90ac5b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA076122
- Marketing category
- ANDA
- Marketing start
- 2026-02-05
- 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, 311726, 314111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-076-01 | Mirtazapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 3 |
| 48433-076-20 | Mirtazapine | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-076-01 | 48433007601 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-076-20 | 48433007620 | 100 BLISTER PACK in 1 CARTON (48433-076-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-076-01) | 100 blister pack | 2026-02-05 | No | No | Historical |