Mirtazapine
- Product NDC
- 0615-8269
- 11-digit product format
- 006158269
- Labeler code
- 0615
- Product ID
- 0615-8269_bc6ac7f8-bb01-4a98-b809-cdf6964d415d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2009-08-17
- Substance
- MIRTAZAPINE
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 311725, 314111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8269-05 | Mirtazapine | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 1 |
| 0615-8269-39 | 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 |
|---|
| 0615-8269 | MIRTAZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190312_20a724c6-feba-40e7-a35a-8a37de2e0136.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 |
|---|
| 0615-8269-05 | 00615826905 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8269-05) | 2019-02-18 | 0000-00-00 | No | No | Current |
| 0615-8269-39 | 00615826939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8269-39) | 2019-02-18 | 0000-00-00 | No | No | Current |