doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler amneal pharmaceuticals ny llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

doxepin hydrochloride 50 mg/g

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1733
Product ID 69238-1733_f44f392e-0f43-4e5d-a2c4-0b15387d67ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212357
Listing Expiration 2026-12-31
Marketing Start 2023-08-21

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381733
Hyphenated Format 69238-1733

Supplemental Identifiers

RxCUI
1000091
UPC
0369238173369
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 ANDA212357 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69238-1733-6) / 45 g in 1 TUBE
source: ndc

Packages (1)

69238-1733-6 1 TUBE in 1 CARTON (69238-1733-6) / 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": "f44f392e-0f43-4e5d-a2c4-0b15387d67ac", "openfda": {"upc": ["0369238173369"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000091"], "spl_set_id": ["dd8d5edd-7b08-4061-86e6-c4179da89c0d"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69238-1733-6)  / 45 g in 1 TUBE", "package_ndc": "69238-1733-6", "marketing_start_date": "20230821"}], "brand_name": "Doxepin Hydrochloride", "product_id": "69238-1733_f44f392e-0f43-4e5d-a2c4-0b15387d67ac", "dosage_form": "CREAM", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "69238-1733", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "50 mg/g"}], "application_number": "ANDA212357", "marketing_category": "ANDA", "marketing_start_date": "20230821", "listing_expiration_date": "20261231"}