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 CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 25 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4218
Product ID 51672-4218_40d409a6-54af-c970-e063-6394a90aa1cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213063
Marketing Start 2020-07-01
Marketing End 2026-03-31

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724218
Hyphenated Format 51672-4218

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0351672421816 0351672421915 0351672422011
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 ANDA213063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (51672-4218-1)
source: ndc

Packages (1)

51672-4218-1 100 CAPSULE in 1 BOTTLE (51672-4218-1)

Ingredients (1)

doxepin hydrochloride (25 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": "40d409a6-54af-c970-e063-6394a90aa1cf", "openfda": {"upc": ["0351672421816", "0351672421915", "0351672422011"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["e5f35807-3db1-4387-8c37-693d9170b51b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (51672-4218-1)", "package_ndc": "51672-4218-1", "marketing_end_date": "20260331", "marketing_start_date": "20200701"}], "brand_name": "DOXEPIN HYDROCHLORIDE", "product_id": "51672-4218_40d409a6-54af-c970-e063-6394a90aa1cf", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "51672-4218", "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": "25 mg/1"}], "application_number": "ANDA213063", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20200701"}