doxepin

Generic: doxepin

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

Drug Facts

Product Profile

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

doxepin hydrochloride 6 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-281
Product ID 27241-281_7b7e70e8-815c-4ba4-9a9a-e7b5627ed6ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218564
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241281
Hyphenated Format 27241-281

Supplemental Identifiers

RxCUI
966787 966793
UPC
0327241281303 0327241280306
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 (source: ndc)
Generic Name doxepin (source: ndc)
Application Number ANDA218564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (27241-281-30)
source: ndc

Packages (1)

27241-281-30 30 TABLET in 1 BOTTLE (27241-281-30)

Ingredients (1)

doxepin hydrochloride (6 mg/1)

Linked Drug Pages (1)

Doxepin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7b7e70e8-815c-4ba4-9a9a-e7b5627ed6ea", "openfda": {"upc": ["0327241281303", "0327241280306"], "unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["b198ade7-fe78-437e-82b4-693dfe45ab51"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (27241-281-30)", "package_ndc": "27241-281-30", "marketing_start_date": "20240701"}], "brand_name": "Doxepin", "product_id": "27241-281_7b7e70e8-815c-4ba4-9a9a-e7b5627ed6ea", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "27241-281", "generic_name": "Doxepin", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA218564", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}