doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler ajanta pharma usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 75 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-170
Product ID 27241-170_4f6891be-49a9-4884-a1ce-35e148c7c156
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212624
Listing Expiration 2026-12-31
Marketing Start 2019-12-20

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241170
Hyphenated Format 27241-170

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0327241167010 0327241170010 0327241171017 0327241169014 0327241168017
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 ANDA212624 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (27241-170-01)
  • 1000 CAPSULE in 1 BOTTLE (27241-170-10)
source: ndc

Packages (2)

27241-170-01 100 CAPSULE in 1 BOTTLE (27241-170-01) 27241-170-10 1000 CAPSULE in 1 BOTTLE (27241-170-10)

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": "4f6891be-49a9-4884-a1ce-35e148c7c156", "openfda": {"upc": ["0327241167010", "0327241170010", "0327241171017", "0327241169014", "0327241168017"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["1513c98c-e7ef-4009-b932-6757048bb86a"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (27241-170-01)", "package_ndc": "27241-170-01", "marketing_start_date": "20191220"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (27241-170-10)", "package_ndc": "27241-170-10", "marketing_start_date": "20200220"}], "brand_name": "Doxepin hydrochloride", "product_id": "27241-170_4f6891be-49a9-4884-a1ce-35e148c7c156", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "27241-170", "generic_name": "Doxepin hydrochloride", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA212624", "marketing_category": "ANDA", "marketing_start_date": "20191220", "listing_expiration_date": "20261231"}