doxepin

Generic: doxepin

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin
Generic Name doxepin
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 6 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-182
Product ID 72578-182_d569143c-aee2-4e03-988d-1ef10950e7ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202761
Listing Expiration 2026-12-31
Marketing Start 2024-06-30

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578182
Hyphenated Format 72578-182

Supplemental Identifiers

RxCUI
966787 966793
UPC
0372578181062 0372578182069
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 ANDA202761 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-182-01)
  • 500 TABLET in 1 BOTTLE (72578-182-05)
  • 30 TABLET in 1 BOTTLE (72578-182-06)
  • 1000 TABLET in 1 BOTTLE (72578-182-10)
  • 90 TABLET in 1 BOTTLE (72578-182-16)
  • 10 BLISTER PACK in 1 CARTON (72578-182-77) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (6)

72578-182-01 100 TABLET in 1 BOTTLE (72578-182-01) 72578-182-05 500 TABLET in 1 BOTTLE (72578-182-05) 72578-182-06 30 TABLET in 1 BOTTLE (72578-182-06) 72578-182-10 1000 TABLET in 1 BOTTLE (72578-182-10) 72578-182-16 90 TABLET in 1 BOTTLE (72578-182-16) 72578-182-77 10 BLISTER PACK in 1 CARTON (72578-182-77) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

doxepin hydrochloride (6 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": "d569143c-aee2-4e03-988d-1ef10950e7ce", "openfda": {"upc": ["0372578181062", "0372578182069"], "unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["3377541d-db46-4fd9-9a4b-faa5f6108e67"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-182-01)", "package_ndc": "72578-182-01", "marketing_start_date": "20240630"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72578-182-05)", "package_ndc": "72578-182-05", "marketing_start_date": "20240630"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72578-182-06)", "package_ndc": "72578-182-06", "marketing_start_date": "20240630"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72578-182-10)", "package_ndc": "72578-182-10", "marketing_start_date": "20240630"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72578-182-16)", "package_ndc": "72578-182-16", "marketing_start_date": "20240630"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-182-77)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "72578-182-77", "marketing_start_date": "20240630"}], "brand_name": "doxepin", "product_id": "72578-182_d569143c-aee2-4e03-988d-1ef10950e7ce", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72578-182", "generic_name": "doxepin", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "doxepin", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA202761", "marketing_category": "ANDA", "marketing_start_date": "20240630", "listing_expiration_date": "20261231"}