Mirtazapine
- Product NDC
- 67046-478
- 11-digit product format
- 670460478
- Labeler code
- 67046
- Product ID
- 67046-478_5aa52c22-f6b9-421c-e053-2991aa0aaf46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Contract Pharmacy Services-PA
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2017-10-03
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 45 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67046-478-07 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 67046-478-14 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 67046-478-15 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 67046-478-20 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 67046-478-21 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 67046-478-28 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 67046-478-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 67046-478-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c7f-a426-e053-dadaa90af4c2 | 484 Mirtazapine 30 mg 478 Mirtazapine 45 mg Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-478-07 | Mirtazapine | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 1 |
| 67046-478-14 | Mirtazapine | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 1 |
| 67046-478-15 | Mirtazapine | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 1 |
| 67046-478-20 | Mirtazapine | 20 in 1 BLISTER PACK | TABLET, FILM COATED | 20 | | 1 |
| 67046-478-21 | Mirtazapine | 21 in 1 BLISTER PACK | TABLET, FILM COATED | 21 | | 1 |
| 67046-478-28 | Mirtazapine | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 1 |
| 67046-478-30 | Mirtazapine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
| 67046-478-60 | Mirtazapine | 60 in 1 BLISTER PACK | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-478 | MIRTAZAPINE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA] | 1 | Legacy NDC, 8 package rows | 20171003_5aa52c22-f6b8-421c-e053-2991aa0aaf46.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 |
|---|
| 67046-478-07 | 67046047807 | 7 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-07) | 2017-10-03 | 0000-00-00 | No | No | Current |
| 67046-478-14 | 67046047814 | 14 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-14) | 2017-10-03 | 0000-00-00 | No | No | Current |
| 67046-478-15 | 67046047815 | 15 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-15) | 2017-10-03 | 0000-00-00 | No | No | Current |
| 67046-478-20 | 67046047820 | 20 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-20) | 2017-10-03 | 0000-00-00 | No | No | Current |
| 67046-478-21 | 67046047821 | 21 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-21) | 2017-10-03 | 0000-00-00 | No | No | Current |
| 67046-478-28 | 67046047828 | 28 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-28) | 2017-10-03 | 0000-00-00 | No | No | Current |
| 67046-478-30 | 67046047830 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-30) | 2017-10-03 | 0000-00-00 | No | No | Current |
| 67046-478-60 | 67046047860 | 60 TABLET, FILM COATED in 1 BLISTER PACK (67046-478-60) | 2017-10-03 | 0000-00-00 | No | No | Current |