doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-011
Product ID 82804-011_7cfbb3d0-f19f-4977-ad0f-77676a8c6f83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212624
Listing Expiration 2026-12-31
Marketing Start 2019-12-20

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804011
Hyphenated Format 82804-011

Supplemental Identifiers

RxCUI
1000070
UPC
0382804011308
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 ANDA212624 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (82804-011-30)
  • 60 CAPSULE in 1 BOTTLE (82804-011-60)
  • 90 CAPSULE in 1 BOTTLE (82804-011-90)
source: ndc

Packages (3)

82804-011-30 30 CAPSULE in 1 BOTTLE (82804-011-30) 82804-011-60 60 CAPSULE in 1 BOTTLE (82804-011-60) 82804-011-90 90 CAPSULE in 1 BOTTLE (82804-011-90)

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": "7cfbb3d0-f19f-4977-ad0f-77676a8c6f83", "openfda": {"upc": ["0382804011308"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000070"], "spl_set_id": ["7cfbb3d0-f19f-4977-ad0f-77676a8c6f83"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (82804-011-30)", "package_ndc": "82804-011-30", "marketing_start_date": "20230921"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (82804-011-60)", "package_ndc": "82804-011-60", "marketing_start_date": "20230921"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (82804-011-90)", "package_ndc": "82804-011-90", "marketing_start_date": "20230921"}], "brand_name": "Doxepin hydrochloride", "product_id": "82804-011_7cfbb3d0-f19f-4977-ad0f-77676a8c6f83", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "82804-011", "generic_name": "Doxepin hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA212624", "marketing_category": "ANDA", "marketing_start_date": "20191220", "listing_expiration_date": "20261231"}