Mirtazapine
- Product NDC
- 43353-962
- 11-digit product format
- 433530962
- Labeler code
- 43353
- Product ID
- 43353-962_9a4d6413-815d-46e3-b9df-680c2671567c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076122
- Marketing category
- ANDA
- Marketing start
- 2012-12-28
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-962-15 | Mirtazapine | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 2 |
| 43353-962-30 | Mirtazapine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 43353-962-45 | Mirtazapine | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 2 |
| 43353-962-53 | Mirtazapine | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-962 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 4 package rows | 20191224_03395e21-ea63-4a4b-b1e0-418c414a35fc.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 |
|---|
| 43353-962-15 | 43353096215 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-15) | 2014-09-16 | 0000-00-00 | No | No | Current |
| 43353-962-30 | 43353096230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-30) | 2014-09-10 | 0000-00-00 | No | No | Current |
| 43353-962-45 | 43353096245 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-45) | 2014-09-19 | 0000-00-00 | No | No | Current |
| 43353-962-53 | 43353096253 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-962-53) | 2014-09-22 | 0000-00-00 | No | No | Current |