doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-331
Product ID 43353-331_a3797445-680f-449e-8ffd-522445906bdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070791
Listing Expiration 2026-12-31
Marketing Start 1986-05-13

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353331
Hyphenated Format 43353-331

Supplemental Identifiers

RxCUI
1000048 1000070
UNII
3U9A0FE9N5

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 ANDA070791 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-09)
  • 6000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-16)
source: ndc

Packages (2)

43353-331-09 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-09) 43353-331-16 6000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-16)

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": "a3797445-680f-449e-8ffd-522445906bdb", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000070"], "spl_set_id": ["10d9eba6-30d1-448a-8d92-a1a02df03303"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-09)", "package_ndc": "43353-331-09", "marketing_start_date": "20170521"}, {"sample": false, "description": "6000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-16)", "package_ndc": "43353-331-16", "marketing_start_date": "20170525"}], "brand_name": "Doxepin Hydrochloride", "product_id": "43353-331_a3797445-680f-449e-8ffd-522445906bdb", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "43353-331", "generic_name": "doxepin hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA070791", "marketing_category": "ANDA", "marketing_start_date": "19860513", "listing_expiration_date": "20261231"}