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
- Substance
- MIRTAZAPINE
- Active strength
- 7.5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| A051Q2099Q | MIRTAZAPINE | 85650-52-8 | MIRTAZAPINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8489-05 | 00615848905 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8489-05) | 2023-09-15 | No | No | Historical |
| 0615-8489-39 | 00615848939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8489-39) | 2023-09-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Mirtazapine | NCS HealthCare of KY, LLC dba Vangard Labs | 2023-09-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |