doxepin

Generic: doxepin

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin
Generic Name doxepin
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doxepin hydrochloride 3 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-758
Product ID 10135-758_43029ddd-8941-add8-e063-6394a90a1e4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202337
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135758
Hyphenated Format 10135-758

Supplemental Identifiers

RxCUI
966787 966793
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 (source: ndc)
Generic Name doxepin (source: ndc)
Application Number ANDA202337 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (10135-758-30)
source: ndc

Packages (1)

10135-758-30 30 TABLET, FILM COATED in 1 BOTTLE (10135-758-30)

Ingredients (1)

doxepin hydrochloride (3 mg/1)

Linked Drug Pages (1)

Doxepin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43029ddd-8941-add8-e063-6394a90a1e4d", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["06e79a65-1455-804e-e063-6394a90a2f3d"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (10135-758-30)", "package_ndc": "10135-758-30", "marketing_start_date": "20231001"}], "brand_name": "Doxepin", "product_id": "10135-758_43029ddd-8941-add8-e063-6394a90a1e4d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "10135-758", "generic_name": "Doxepin", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA202337", "marketing_category": "ANDA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}