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Mirtazapine - Medication Information

Product NDC Code 76483-110
Drug Name

Mirtazapine

Type Generic
Active Ingredients
Mirtazapine 15 mg/1
Route ORAL
Dosage Form TABLET, ORALLY DISINTEGRATING
RxCUI drug identifier 283406,
283407,
283485
Application Number ANDA205798
Labeler Name SQUARE PHARMACEUTICALS LIMITED
Packages
Package NDC Code Description
76483-110-00 30 tablet, orally disintegrating in 1 carton (76483-110-00)
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Spl product data elements

Usually a list of ingredients in a drug product.
Mirtazapine Mirtazapine MIRTAZAPINE MIRTAZAPINE MANNITOL MICROCRYSTALLINE CELLULOSE CROSPOVIDONE POVIDONE K30 ASPARTAME ALPHA-TOCOPHEROL MALTODEXTRIN SILICON DIOXIDE ANHYDROUS CITRIC ACID MAGNESIUM STEARATE SODIUM STEARYL FUMARATE white to off-white 677 Mirtazapine Mirtazapine MIRTAZAPINE MIRTAZAPINE MANNITOL MICROCRYSTALLINE CELLULOSE CROSPOVIDONE POVIDONE K30 ASPARTAME ALPHA-TOCOPHEROL MALTODEXTRIN SILICON DIOXIDE ANHYDROUS CITRIC ACID MAGNESIUM STEARATE SODIUM STEARYL FUMARATE white to off-white 676 Mirtazapine Mirtazapine MIRTAZAPINE MIRTAZAPINE MANNITOL MICROCRYSTALLINE CELLULOSE CROSPOVIDONE POVIDONE K30 ASPARTAME ALPHA-TOCOPHEROL MALTODEXTRIN SILICON DIOXIDE ANHYDROUS CITRIC ACID MAGNESIUM STEARATE SODIUM STEARYL FUMARATE white to off-white 679

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76483-110-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets Mirtazapine Orally Disintegrating Tablets USP, 15 mg Rx only 30 Tablets NDC 76483-111-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets Mirtazapine Orally Disintegrating Tablets USP, 30 mg Rx only 30 Tablets NDC 76483-112-00 in unit-dose blister cartons of 30 (5 x 6 blisters) Unit-of-use Tablets Mirtazapine Orally Disintegrating Tablets USP, 45 mg Rx only 30 Tablets Mirtazapine Orally Disintegrating Tablets USP, 15 mg Mirtazapine Orally Disintegrating Tablets USP, 30 mg Mirtazapine Orally Disintegrating Tablets USP, 45 mg

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API