doxepin hydrochloride

Generic: doxepin hydrochloride

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

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 3 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-052
Product ID 72205-052_97c3bda8-3dbe-4c7a-aee9-00418c11d24c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214823
Listing Expiration 2026-12-31
Marketing Start 2023-04-05

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205052
Hyphenated Format 72205-052

Supplemental Identifiers

RxCUI
966787 966793
UPC
0372205052918 0372205052307 0372205053915
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 ANDA214823 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (72205-052-05)
  • 30 TABLET in 1 BOTTLE (72205-052-30)
  • 100 TABLET in 1 BOTTLE (72205-052-91)
source: ndc

Packages (3)

72205-052-05 500 TABLET in 1 BOTTLE (72205-052-05) 72205-052-30 30 TABLET in 1 BOTTLE (72205-052-30) 72205-052-91 100 TABLET in 1 BOTTLE (72205-052-91)

Ingredients (1)

doxepin hydrochloride (3 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": "97c3bda8-3dbe-4c7a-aee9-00418c11d24c", "openfda": {"upc": ["0372205052918", "0372205052307", "0372205053915"], "unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["96086fd8-8fa3-4a2b-ac12-fe1a3ad4f384"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (72205-052-05)", "package_ndc": "72205-052-05", "marketing_start_date": "20230405"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72205-052-30)", "package_ndc": "72205-052-30", "marketing_start_date": "20230405"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72205-052-91)", "package_ndc": "72205-052-91", "marketing_start_date": "20230405"}], "brand_name": "Doxepin hydrochloride", "product_id": "72205-052_97c3bda8-3dbe-4c7a-aee9-00418c11d24c", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72205-052", "generic_name": "Doxepin hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA214823", "marketing_category": "ANDA", "marketing_start_date": "20230405", "listing_expiration_date": "20261231"}