doxepin

Generic: doxepin

Labeler: north star rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin
Generic Name doxepin
Labeler north star rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doxepin hydrochloride 3 mg/1

Manufacturer
North Star Rx LLC

Identifiers & Regulatory

Product NDC 72603-222
Product ID 72603-222_472f1364-17cc-0996-e063-6394a90aa786
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202337
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603222
Hyphenated Format 72603-222

Supplemental Identifiers

RxCUI
966787 966793
UPC
0372603222012 0372603223019
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 (72603-222-01)
source: ndc

Packages (1)

72603-222-01 30 TABLET, FILM COATED in 1 BOTTLE (72603-222-01)

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": "472f1364-17cc-0996-e063-6394a90aa786", "openfda": {"upc": ["0372603222012", "0372603223019"], "unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["12edd5c6-c863-b83a-e063-6294a90a2f36"], "manufacturer_name": ["North Star Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72603-222-01)", "package_ndc": "72603-222-01", "marketing_start_date": "20240401"}], "brand_name": "Doxepin", "product_id": "72603-222_472f1364-17cc-0996-e063-6394a90aa786", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72603-222", "generic_name": "Doxepin", "labeler_name": "North Star Rx LLC", "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": "20240401", "listing_expiration_date": "20261231"}