doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 25 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0316
Product ID 80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213063
Listing Expiration 2026-12-31
Marketing Start 2023-04-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250316
Hyphenated Format 80425-0316

Supplemental Identifiers

RxCUI
1000070
UNII
3U9A0FE9N5

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 ANDA213063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0316-1)
  • 60 CAPSULE in 1 BOTTLE (80425-0316-2)
  • 90 CAPSULE in 1 BOTTLE (80425-0316-3)
source: ndc

Packages (3)

80425-0316-1 30 CAPSULE in 1 BOTTLE (80425-0316-1) 80425-0316-2 60 CAPSULE in 1 BOTTLE (80425-0316-2) 80425-0316-3 90 CAPSULE in 1 BOTTLE (80425-0316-3)

Ingredients (1)

doxepin hydrochloride (25 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": "2a9bf621-afbf-7627-e063-6294a90a77a9", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000070"], "spl_set_id": ["f900bac4-02f2-6bf3-e053-6394a90a2161"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0316-1)", "package_ndc": "80425-0316-1", "marketing_start_date": "20230410"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (80425-0316-2)", "package_ndc": "80425-0316-2", "marketing_start_date": "20230410"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (80425-0316-3)", "package_ndc": "80425-0316-3", "marketing_start_date": "20230410"}], "brand_name": "Doxepin Hydrochloride", "product_id": "80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "80425-0316", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA213063", "marketing_category": "ANDA", "marketing_start_date": "20230410", "listing_expiration_date": "20261231"}