doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler leading pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 75 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-161
Product ID 69315-161_5cc7cb1d-f51f-4a92-8bd2-59c037df9987
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211619
Listing Expiration 2026-12-31
Marketing Start 2021-04-15

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315161
Hyphenated Format 69315-161

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0369315161104 0369315159019 0369315160107 0369315162101 0369315162019 0369315160015 0369315161012
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 hydrochloride (source: ndc)
Generic Name doxepin hydrochloride (source: ndc)
Application Number ANDA211619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 PACKAGE (69315-161-01)
  • 1000 CAPSULE in 1 PACKAGE (69315-161-10)
source: ndc

Packages (2)

69315-161-01 100 CAPSULE in 1 PACKAGE (69315-161-01) 69315-161-10 1000 CAPSULE in 1 PACKAGE (69315-161-10)

Ingredients (1)

doxepin hydrochloride (75 mg/1)

Linked Drug Pages (1)

DOXEPIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5cc7cb1d-f51f-4a92-8bd2-59c037df9987", "openfda": {"upc": ["0369315161104", "0369315159019", "0369315160107", "0369315162101", "0369315162019", "0369315160015", "0369315161012"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["e6a4cb10-1928-4abe-8797-404c9ddc37dd"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 PACKAGE (69315-161-01)", "package_ndc": "69315-161-01", "marketing_start_date": "20210415"}, {"sample": false, "description": "1000 CAPSULE in 1 PACKAGE (69315-161-10)", "package_ndc": "69315-161-10", "marketing_start_date": "20210415"}], "brand_name": "DOXEPIN HYDROCHLORIDE", "product_id": "69315-161_5cc7cb1d-f51f-4a92-8bd2-59c037df9987", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "69315-161", "generic_name": "DOXEPIN HYDROCHLORIDE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXEPIN HYDROCHLORIDE", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA211619", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20261231"}