doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: appco pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler appco pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 10 mg/1

Manufacturer
Appco Pharma LLC

Identifiers & Regulatory

Product NDC 55801-527
Product ID 55801-527_897d1512-3e1a-469e-bcb9-131e514ed562
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214908
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55801527
Hyphenated Format 55801-527

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0355801529015 0355801530028 0355801527011 0355801528025
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
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (55801-527-01)
  • 500 CAPSULE in 1 BOTTLE (55801-527-02)
source: ndc

Packages (2)

55801-527-01 100 CAPSULE in 1 BOTTLE (55801-527-01) 55801-527-02 500 CAPSULE in 1 BOTTLE (55801-527-02)

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": "897d1512-3e1a-469e-bcb9-131e514ed562", "openfda": {"upc": ["0355801529015", "0355801530028", "0355801527011", "0355801528025"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["abf4c515-8888-4733-80a0-fd4e1cdb84a2"], "manufacturer_name": ["Appco Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (55801-527-01)", "package_ndc": "55801-527-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (55801-527-02)", "package_ndc": "55801-527-02", "marketing_start_date": "20210601"}], "brand_name": "Doxepin Hydrochloride", "product_id": "55801-527_897d1512-3e1a-469e-bcb9-131e514ed562", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "55801-527", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Appco Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA214908", "marketing_category": "ANDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}