silenor

Generic: doxepin hydrochloride

Labeler: currax pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name silenor
Generic Name doxepin hydrochloride
Labeler currax pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxepin hydrochloride 3 mg/1

Manufacturer
Currax Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 42847-103
Product ID 42847-103_1a9b50b3-afcb-4b7b-a891-5fd1da5709c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022036
Listing Expiration 2026-12-31
Marketing Start 2010-08-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42847103
Hyphenated Format 42847-103

Supplemental Identifiers

RxCUI
966787 966791 966793 966795
UPC
0342847103309 0342847106300
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 silenor (source: ndc)
Generic Name doxepin hydrochloride (source: ndc)
Application Number NDA022036 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (42847-103-03)
  • 100 TABLET in 1 BOTTLE (42847-103-10)
  • 30 TABLET in 1 BOTTLE (42847-103-30)
  • 500 TABLET in 1 BOTTLE (42847-103-50)
source: ndc

Packages (4)

42847-103-03 30 TABLET in 1 BLISTER PACK (42847-103-03) 42847-103-10 100 TABLET in 1 BOTTLE (42847-103-10) 42847-103-30 30 TABLET in 1 BOTTLE (42847-103-30) 42847-103-50 500 TABLET in 1 BOTTLE (42847-103-50)

Ingredients (1)

doxepin hydrochloride (3 mg/1)

Linked Drug Pages (1)

Silenor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a9b50b3-afcb-4b7b-a891-5fd1da5709c8", "openfda": {"upc": ["0342847103309", "0342847106300"], "unii": ["3U9A0FE9N5"], "rxcui": ["966787", "966791", "966793", "966795"], "spl_set_id": ["1bec1223-5239-4eb6-a9e8-62444106d2c0"], "manufacturer_name": ["Currax Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (42847-103-03)", "package_ndc": "42847-103-03", "marketing_start_date": "20100801"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (42847-103-10)", "package_ndc": "42847-103-10", "marketing_start_date": "20100801"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42847-103-30)", "package_ndc": "42847-103-30", "marketing_start_date": "20100801"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42847-103-50)", "package_ndc": "42847-103-50", "marketing_start_date": "20100801"}], "brand_name": "Silenor", "product_id": "42847-103_1a9b50b3-afcb-4b7b-a891-5fd1da5709c8", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "42847-103", "generic_name": "doxepin hydrochloride", "labeler_name": "Currax Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Silenor", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "NDA022036", "marketing_category": "NDA", "marketing_start_date": "20100801", "listing_expiration_date": "20261231"}