Mirtazapine
- Product NDC
- 0615-8489
- 11-digit product format
- 006158489
- Labeler code
- 0615
- Product ID
- 0615-8489_638be761-770a-4310-9296-00aa4a184425
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2004-10-22
- Marketing end
- 2026-12-31
- 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
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRTAZAPINE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8489-05 | Mirtazapine | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 1 |
| 0615-8489-39 | Mirtazapine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8489 | MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 2 package rows | 20230919_70439462-b632-4d21-8067-560162db3137.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 |
|---|
| 0615-8489-05 | 00615848905 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8489-05) | 2023-09-15 | 2026-12-31 | No | No | Historical |
| 0615-8489-39 | 00615848939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8489-39) | 2023-09-15 | 2026-12-31 | No | No | Historical |