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, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 15 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1397
Product ID 70518-1397_48fba7b0-90d0-f973-e063-6394a90a9672
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2027-12-31
Marketing Start 2018-08-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181397
Hyphenated Format 70518-1397

Supplemental Identifiers

RxCUI
311725
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 ANDA076921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1397-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1397-1)
source: ndc

Packages (2)

70518-1397-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1397-0) 70518-1397-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1397-1)

Ingredients (1)

mirtazapine (15 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": "48fba7b0-90d0-f973-e063-6394a90a9672", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["311725"], "spl_set_id": ["9135e7db-cba4-4150-a69c-fdf2a347a785"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1397-0)", "package_ndc": "70518-1397-0", "marketing_start_date": "20180831"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1397-1)", "package_ndc": "70518-1397-1", "marketing_start_date": "20250823"}], "brand_name": "Mirtazapine", "product_id": "70518-1397_48fba7b0-90d0-f973-e063-6394a90a9672", "dosage_form": "TABLET, FILM COATED", "product_ndc": "70518-1397", "generic_name": "Mirtazapine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20180831", "listing_expiration_date": "20271231"}