Mirtazapine
- Product NDC
- 71610-115
- 11-digit product format
- 716100115
- Labeler code
- 71610
- Product ID
- 71610-115_741ce88a-0753-461f-b456-4d026b540985
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2004-10-22
- 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 |
|---|
| 71610-115-15 | Mirtazapine | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 71610-115-30 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 71610-115-60 | Mirtazapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-115 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20180829_3bda4994-cdf5-47b4-aebc-7297347334e9.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 |
|---|
| 71610-115-15 | 71610011515 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-115-15) | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71610-115-30 | 71610011530 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-115-30) | 2018-08-09 | 0000-00-00 | No | No | Current |
| 71610-115-60 | 71610011560 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-115-60) | 2018-08-09 | 0000-00-00 | No | No | Current |