Mirtazapine Tablet, Orally Disintegrating
FDA Label NDC 76483-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Square Pharmaceuticals Limited for the product Mirtazapine (NDC 76483-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Mirtazapine Orally Disintegrating Tablets Usp, 15 mg (B24e0ecd 3a9d 4515 8c84 382de235c65b 01)

Mirtazapine Orally Disintegrating Tablets Usp, 15 mg (B24e0ecd 3a9d 4515 8c84 382de235c65b 01)

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

Mirtazapine Orally Disintegrating Tablets Usp, 30 mg (B24e0ecd 3a9d 4515 8c84 382de235c65b 02)

Mirtazapine Orally Disintegrating Tablets Usp, 30 mg (B24e0ecd 3a9d 4515 8c84 382de235c65b 02)

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, 45 mg (B24e0ecd 3a9d 4515 8c84 382de235c65b 03)

Mirtazapine Orally Disintegrating Tablets Usp, 45 mg (B24e0ecd 3a9d 4515 8c84 382de235c65b 03)

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