doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: first nation group, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler first nation group, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 10 mg/1

Manufacturer
First Nation Group, LLC

Identifiers & Regulatory

Product NDC 81469-415
Product ID 81469-415_55da757c-42d2-4963-b06f-def9f18a423f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215710
Listing Expiration 2026-12-31
Marketing Start 2023-01-11

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81469415
Hyphenated Format 81469-415

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 ANDA215710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (81469-415-01)
  • 500 CAPSULE in 1 BOTTLE (81469-415-05)
source: ndc

Packages (2)

81469-415-01 100 CAPSULE in 1 BOTTLE (81469-415-01) 81469-415-05 500 CAPSULE in 1 BOTTLE (81469-415-05)

Ingredients (1)

doxepin hydrochloride (10 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": "55da757c-42d2-4963-b06f-def9f18a423f", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["3d4f84a4-07a1-4d0e-85f5-dcd43b236a42"], "manufacturer_name": ["First Nation Group, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (81469-415-01)", "package_ndc": "81469-415-01", "marketing_start_date": "20230111"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (81469-415-05)", "package_ndc": "81469-415-05", "marketing_start_date": "20230111"}], "brand_name": "Doxepin Hydrochloride", "product_id": "81469-415_55da757c-42d2-4963-b06f-def9f18a423f", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "81469-415", "generic_name": "doxepin hydrochloride", "labeler_name": "First Nation Group, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA215710", "marketing_category": "ANDA", "marketing_start_date": "20230111", "listing_expiration_date": "20261231"}