Mirtazapine
- Product NDC
- 43353-535
- 11-digit product format
- 433530535
- Labeler code
- 43353
- Product ID
- 43353-535_d9c085ee-2ef8-4ad3-8890-b423b1daed44
- 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
- 2009-08-17
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 15 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 |
|---|
| 43353-535-15 | 2023-01-30 | C162847 | 48780-1 | f386c649-f501-0266-e053-dadaa90a7c1a | Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 43353-535-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-f501-0266-e053-dadaa90a7c1a | Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 43353-535-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-f501-0266-e053-dadaa90a7c1a | 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 |
|---|
| 43353-535-15 | Mirtazapine | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 3 |
| 43353-535-30 | Mirtazapine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 43353-535-60 | Mirtazapine | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Mirtazapine | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| Mirtazapine | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-535 | MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 3 package rows | 20191224_75dd7e5b-32ec-433b-8379-11cfb372f0d0.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 |
|---|
| 43353-535-15 | 43353053515 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-535-15) | 2009-09-08 | 0000-00-00 | No | No | Current |
| 43353-535-30 | 43353053530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-535-30) | 2010-03-23 | 0000-00-00 | No | No | Current |
| 43353-535-60 | 43353053560 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-535-60) | 2009-09-08 | 0000-00-00 | No | No | Current |