doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 75 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-797
Product ID 23155-797_89ed6385-cf6a-458e-81ea-c7f3fead41c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214908
Listing Expiration 2026-12-31
Marketing Start 2021-12-30

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155797
Hyphenated Format 23155-797

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
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 ANDA214908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (23155-797-01)
source: ndc

Packages (1)

23155-797-01 100 CAPSULE in 1 BOTTLE (23155-797-01)

Ingredients (1)

doxepin hydrochloride (75 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": "89ed6385-cf6a-458e-81ea-c7f3fead41c5", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["89ed6385-cf6a-458e-81ea-c7f3fead41c5"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (23155-797-01)", "package_ndc": "23155-797-01", "marketing_start_date": "20211230"}], "brand_name": "Doxepin Hydrochloride", "product_id": "23155-797_89ed6385-cf6a-458e-81ea-c7f3fead41c5", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "23155-797", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA214908", "marketing_category": "ANDA", "marketing_start_date": "20211230", "listing_expiration_date": "20261231"}