doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

doxepin hydrochloride 50 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8117
Product ID 0378-8117_b4771ea7-c19b-4182-bb23-c1473ab583fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020126
Listing Expiration 2026-12-31
Marketing Start 2019-01-04

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788117
Hyphenated Format 0378-8117

Supplemental Identifiers

RxCUI
1000091
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 NDA020126 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-8117-45) / 45 g in 1 TUBE
source: ndc

Packages (1)

0378-8117-45 1 TUBE in 1 CARTON (0378-8117-45) / 45 g in 1 TUBE

Ingredients (1)

doxepin hydrochloride (50 mg/g)

Linked Drug Pages (1)

Doxepin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "b4771ea7-c19b-4182-bb23-c1473ab583fa", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000091"], "spl_set_id": ["b4771ea7-c19b-4182-bb23-c1473ab583fa"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-8117-45)  / 45 g in 1 TUBE", "package_ndc": "0378-8117-45", "marketing_start_date": "20190104"}], "brand_name": "Doxepin Hydrochloride", "product_id": "0378-8117_b4771ea7-c19b-4182-bb23-c1473ab583fa", "dosage_form": "CREAM", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "0378-8117", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "50 mg/g"}], "application_number": "NDA020126", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190104", "listing_expiration_date": "20261231"}