mirtazapine

Generic: mirtazapine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mirtazapine 30 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4548
Product ID 70518-4548_48bdcb5d-498e-4412-e063-6394a90ad87f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076541
Listing Expiration 2027-12-31
Marketing Start 2026-01-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184548
Hyphenated Format 70518-4548

Supplemental Identifiers

RxCUI
314111
UNII
A051Q2099Q

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mirtazapine (source: ndc)
Generic Name mirtazapine (source: ndc)
Application Number ANDA076541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-4548-0)
source: ndc

Packages (1)

70518-4548-0 30 TABLET in 1 BOTTLE, PLASTIC (70518-4548-0)

Ingredients (1)

mirtazapine (30 mg/1)

Linked Drug Pages (1)

Mirtazapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48bdcb5d-498e-4412-e063-6394a90ad87f", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["314111"], "spl_set_id": ["e708e8bb-9b13-44d9-96f5-fd73a893a987"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (70518-4548-0)", "package_ndc": "70518-4548-0", "marketing_start_date": "20260118"}], "brand_name": "Mirtazapine", "product_id": "70518-4548_48bdcb5d-498e-4412-e063-6394a90ad87f", "dosage_form": "TABLET", "product_ndc": "70518-4548", "generic_name": "Mirtazapine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "30 mg/1"}], "application_number": "ANDA076541", "marketing_category": "ANDA", "marketing_start_date": "20260118", "listing_expiration_date": "20271231"}