Mirtazapine
- Product NDC
- 72603-558
- 11-digit product format
- 726030558
- Labeler code
- 72603
- Product ID
- 72603-558_979eec8b-1bf4-466b-812e-85a111ce1cb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2025-04-01
- 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 |
|---|
| 72603-558-01 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 72603-558-02 | Mirtazapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-558 | MIRTAZAPINE TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | Current NDC, 2 package rows | 20250402_979eec8b-1bf4-466b-812e-85a111ce1cb5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-558-01 | 72603055801 | 30 TABLET, FILM COATED in 1 BOTTLE (72603-558-01) | 2025-04-01 | No | No | Current |
| 72603-558-02 | 72603055802 | 500 TABLET, FILM COATED in 1 BOTTLE (72603-558-02) | 2025-04-01 | No | No | Current |