mirtazapine

Generic: mirtazapine

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirtazapine
Generic Name mirtazapine
Labeler atlantic biologicals corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mirtazapine 7.5 mg/1

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0101
Product ID 17856-0101_3892e59b-daa3-17b8-e063-6394a90a00f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076921
Listing Expiration 2026-12-31
Marketing Start 2009-08-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560101
Hyphenated Format 17856-0101

Supplemental Identifiers

RxCUI
476809
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
  • 7.5 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX, UNIT-DOSE (17856-0101-1) / 1 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (1)

17856-0101-1 100 POUCH in 1 BOX, UNIT-DOSE (17856-0101-1) / 1 TABLET, FILM COATED in 1 POUCH

Ingredients (1)

mirtazapine (7.5 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": "3892e59b-daa3-17b8-e063-6394a90a00f5", "openfda": {"unii": ["A051Q2099Q"], "rxcui": ["476809"], "spl_set_id": ["e6e5cbf7-a958-4ef8-abcc-a7491edb9520"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX, UNIT-DOSE (17856-0101-1)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "17856-0101-1", "marketing_start_date": "20210512"}], "brand_name": "Mirtazapine", "product_id": "17856-0101_3892e59b-daa3-17b8-e063-6394a90a00f5", "dosage_form": "TABLET, FILM COATED", "product_ndc": "17856-0101", "generic_name": "Mirtazapine", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirtazapine", "active_ingredients": [{"name": "MIRTAZAPINE", "strength": "7.5 mg/1"}], "application_number": "ANDA076921", "marketing_category": "ANDA", "marketing_start_date": "20090817", "listing_expiration_date": "20261231"}