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 150 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-163
Product ID 69315-163_ab05177e-b4a4-4cc5-b950-441858aaa0ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211618
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 69315163
Hyphenated Format 69315-163

Supplemental Identifiers

RxCUI
1000064
UPC
0369315163016 0369315163504
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 ANDA211618 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 PACKAGE (69315-163-01)
  • 500 CAPSULE in 1 PACKAGE (69315-163-05)
  • 50 CAPSULE in 1 PACKAGE (69315-163-50)
source: ndc

Packages (3)

69315-163-01 100 CAPSULE in 1 PACKAGE (69315-163-01) 69315-163-05 500 CAPSULE in 1 PACKAGE (69315-163-05) 69315-163-50 50 CAPSULE in 1 PACKAGE (69315-163-50)

Ingredients (1)

doxepin hydrochloride (150 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": "ab05177e-b4a4-4cc5-b950-441858aaa0ca", "openfda": {"upc": ["0369315163016", "0369315163504"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000064"], "spl_set_id": ["d5df4beb-8048-4b83-aa59-19876437001d"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 PACKAGE (69315-163-01)", "package_ndc": "69315-163-01", "marketing_start_date": "20210415"}, {"sample": false, "description": "500 CAPSULE in 1 PACKAGE (69315-163-05)", "package_ndc": "69315-163-05", "marketing_start_date": "20210415"}, {"sample": false, "description": "50 CAPSULE in 1 PACKAGE (69315-163-50)", "package_ndc": "69315-163-50", "marketing_start_date": "20210415"}], "brand_name": "DOXEPIN HYDROCHLORIDE", "product_id": "69315-163_ab05177e-b4a4-4cc5-b950-441858aaa0ca", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "69315-163", "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": "150 mg/1"}], "application_number": "ANDA211618", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20261231"}