doxepin

Generic: doxepin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin
Generic Name doxepin
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 3 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-844
Product ID 59651-844_29b3bf98-2c57-4d87-b5eb-5232e46dc639
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216041
Listing Expiration 2026-12-31
Marketing Start 2025-07-12

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651844
Hyphenated Format 59651-844

Supplemental Identifiers

RxCUI
966787 966793
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 ANDA216041 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (59651-844-30)
source: ndc

Packages (1)

59651-844-30 30 TABLET in 1 BOTTLE (59651-844-30)

Ingredients (1)

doxepin hydrochloride (3 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": "29b3bf98-2c57-4d87-b5eb-5232e46dc639", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["29b3bf98-2c57-4d87-b5eb-5232e46dc639"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-844-30)", "package_ndc": "59651-844-30", "marketing_start_date": "20250712"}], "brand_name": "DOXEPIN", "product_id": "59651-844_29b3bf98-2c57-4d87-b5eb-5232e46dc639", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "59651-844", "generic_name": "DOXEPIN", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXEPIN", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA216041", "marketing_category": "ANDA", "marketing_start_date": "20250712", "listing_expiration_date": "20261231"}