doxepin

Generic: doxepin

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin
Generic Name doxepin
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doxepin hydrochloride 6 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-3316
Product ID 0228-3316_84c77416-5f71-4fc9-b00b-964960f27241
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201951
Listing Expiration 2026-12-31
Marketing Start 2020-01-02

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02283316
Hyphenated Format 0228-3316

Supplemental Identifiers

RxCUI
966787 966793
UPC
0302283316039
UNII
3U9A0FE9N5

Packaging Origin

Original Packager
true

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 doxepin (source: ndc)
Generic Name doxepin (source: ndc)
Application Number ANDA201951 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03)
source: ndc

Packages (1)

0228-3316-03 30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03)

Ingredients (1)

doxepin hydrochloride (6 mg/1)

Linked Drug Pages (1)

Doxepin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "84c77416-5f71-4fc9-b00b-964960f27241", "openfda": {"upc": ["0302283316039"], "unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["c42333f8-1add-4f33-9458-6fe4436874a1"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03)", "package_ndc": "0228-3316-03", "marketing_start_date": "20200102"}], "brand_name": "Doxepin", "product_id": "0228-3316_84c77416-5f71-4fc9-b00b-964960f27241", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "0228-3316", "generic_name": "Doxepin", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA201951", "marketing_category": "ANDA", "marketing_start_date": "20200102", "listing_expiration_date": "20261231"}