doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler micro labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 50 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-422
Product ID 42571-422_3a339de3-917e-a3d8-e063-6294a90a6889
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217688
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571422
Hyphenated Format 42571-422

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0342571424015 0342571423018 0342571420017 0342571422011 0342571421014
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 ANDA217688 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42571-422-01)
  • 1000 CAPSULE in 1 BOTTLE (42571-422-13)
source: ndc

Packages (2)

42571-422-01 100 CAPSULE in 1 BOTTLE (42571-422-01) 42571-422-13 1000 CAPSULE in 1 BOTTLE (42571-422-13)

Ingredients (1)

doxepin hydrochloride (50 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": "3a339de3-917e-a3d8-e063-6294a90a6889", "openfda": {"upc": ["0342571424015", "0342571423018", "0342571420017", "0342571422011", "0342571421014"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["8a3ba1fd-de34-47e4-96ca-f3086aed4b76"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42571-422-01)", "package_ndc": "42571-422-01", "marketing_start_date": "20240101"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (42571-422-13)", "package_ndc": "42571-422-13", "marketing_start_date": "20240101"}], "brand_name": "Doxepin Hydrochloride", "product_id": "42571-422_3a339de3-917e-a3d8-e063-6294a90a6889", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "42571-422", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA217688", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}