Mirtazapine
- Product NDC
- 0904-6519
- 11-digit product format
- 009046519
- Labeler code
- 0904
- Product ID
- 0904-6519_2c3b820d-5318-42f7-b94e-2a70d659af71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA077666
- Marketing category
- ANDA
- Marketing start
- 2007-08-22
- 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 |
|---|
| 0904-6519-61 | Mirtazapine | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 11 |
| 0904-6519-61 | Mirtazapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6519 | MIRTAZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250223_a80463be-f2d2-4074-9bd8-5e52b0832b3a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6519-61 | 00904651961 | 100 BLISTER PACK in 1 CARTON (0904-6519-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2007-08-22 | 0000-00-00 | No | No | Current |