doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 3 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4246
Product ID 51672-4246_36adb81c-3442-17dc-e063-6394a90aaafa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219058
Listing Expiration 2026-12-31
Marketing Start 2025-08-07

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724246
Hyphenated Format 51672-4246

Supplemental Identifiers

RxCUI
966787 966793
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 ANDA219058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (51672-4246-2)
source: ndc

Packages (1)

51672-4246-2 30 TABLET in 1 BOTTLE (51672-4246-2)

Ingredients (1)

doxepin hydrochloride (3 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": "36adb81c-3442-17dc-e063-6394a90aaafa", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966793"], "spl_set_id": ["554ab06f-6420-42b3-89d1-d97554c237d8"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (51672-4246-2)", "package_ndc": "51672-4246-2", "marketing_start_date": "20250807"}], "brand_name": "doxepin hydrochloride", "product_id": "51672-4246_36adb81c-3442-17dc-e063-6394a90aaafa", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "51672-4246", "generic_name": "doxepin hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "doxepin hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA219058", "marketing_category": "ANDA", "marketing_start_date": "20250807", "listing_expiration_date": "20261231"}