doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 6 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4297
Product ID 70518-4297_401df14b-32cf-1c71-e063-6394a90a6ad4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214823
Listing Expiration 2026-12-31
Marketing Start 2025-02-27

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184297
Hyphenated Format 70518-4297

Supplemental Identifiers

RxCUI
966793
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 ANDA214823 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-4297-0) / 1 TABLET in 1 POUCH (70518-4297-1)
source: ndc

Packages (1)

70518-4297-0 30 POUCH in 1 BOX (70518-4297-0) / 1 TABLET in 1 POUCH (70518-4297-1)

Ingredients (1)

doxepin hydrochloride (6 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": "401df14b-32cf-1c71-e063-6394a90a6ad4", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["966793"], "spl_set_id": ["7a8c56ab-5dd1-4e1a-b26a-3af45b961dd0"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-4297-0)  / 1 TABLET in 1 POUCH (70518-4297-1)", "package_ndc": "70518-4297-0", "marketing_start_date": "20250227"}], "brand_name": "Doxepin hydrochloride", "product_id": "70518-4297_401df14b-32cf-1c71-e063-6394a90a6ad4", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "70518-4297", "generic_name": "Doxepin hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA214823", "marketing_category": "ANDA", "marketing_start_date": "20250227", "listing_expiration_date": "20261231"}