Mirtazapine
- Product NDC
- 42254-087
- 11-digit product format
- 422540087
- Labeler code
- 42254
- Product ID
- 42254-087_2373655d-ac74-43f5-a041-9f41a5b92206
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076312
- Marketing category
- ANDA
- Marketing start
- 2003-06-01
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 30 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 42254-087-30 | Mirtazapine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 42254-087-60 | Mirtazapine | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIRTAZAPINE | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MIRTAZAPINE | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42254-087 | MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20120411_2373655d-ac74-43f5-a041-9f41a5b92206.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 42254-087-30 | 42254008730 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 42254-087-60 | 42254008760 | 60 in 1 BOTTLE, PLASTIC | Historical |