doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler lannett company, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

doxepin hydrochloride 10 mg/mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 54838-512
Product ID 54838-512_5408fdf5-16a7-4d5a-b4c4-2ccb271759a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074721
Listing Expiration 2026-12-31
Marketing Start 1998-12-29

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54838512
Hyphenated Format 54838-512

Supplemental Identifiers

RxCUI
1000054
UPC
0354838512403
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 ANDA074721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (54838-512-40)
source: ndc

Packages (1)

54838-512-40 120 mL in 1 BOTTLE, PLASTIC (54838-512-40)

Ingredients (1)

doxepin hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Doxepin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5408fdf5-16a7-4d5a-b4c4-2ccb271759a2", "openfda": {"upc": ["0354838512403"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000054"], "spl_set_id": ["f350afed-120b-422d-9e6e-3aaa0f72a5fb"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (54838-512-40)", "package_ndc": "54838-512-40", "marketing_start_date": "19981229"}], "brand_name": "Doxepin Hydrochloride", "product_id": "54838-512_5408fdf5-16a7-4d5a-b4c4-2ccb271759a2", "dosage_form": "SOLUTION", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "54838-512", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA074721", "marketing_category": "ANDA", "marketing_start_date": "19981229", "listing_expiration_date": "20261231"}