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 CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4282
Product ID 70518-4282_4019f5bb-f9ab-92fc-e063-6394a90aa042
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215076
Listing Expiration 2026-12-31
Marketing Start 2025-02-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184282
Hyphenated Format 70518-4282

Supplemental Identifiers

RxCUI
1000076
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 ANDA215076 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (70518-4282-0)
source: ndc

Packages (1)

70518-4282-0 30 CAPSULE in 1 BLISTER PACK (70518-4282-0)

Ingredients (1)

doxepin hydrochloride (50 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": "4019f5bb-f9ab-92fc-e063-6394a90aa042", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000076"], "spl_set_id": ["21dc77be-23af-4a1f-b189-dfee8ae2f894"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-4282-0)", "package_ndc": "70518-4282-0", "marketing_start_date": "20250210"}], "brand_name": "DOXEPIN HYDROCHLORIDE", "product_id": "70518-4282_4019f5bb-f9ab-92fc-e063-6394a90aa042", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "70518-4282", "generic_name": "DOXEPIN HYDROCHLORIDE", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXEPIN HYDROCHLORIDE", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA215076", "marketing_category": "ANDA", "marketing_start_date": "20250210", "listing_expiration_date": "20261231"}