doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7055
Product ID 0904-7055_b96f2236-46f3-47c4-a658-aa3d30f56b0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207482
Listing Expiration 2026-12-31
Marketing Start 2017-06-28

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047055
Hyphenated Format 0904-7055

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076
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 ANDA207482 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7055-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7055-61 100 BLISTER PACK in 1 CARTON (0904-7055-61) / 1 CAPSULE in 1 BLISTER PACK

Ingredients (1)

doxepin hydrochloride (100 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": "b96f2236-46f3-47c4-a658-aa3d30f56b0c", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076"], "spl_set_id": ["df3b6be0-6a64-4174-b351-dab2061f290e"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7055-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7055-61", "marketing_start_date": "20170628"}], "brand_name": "Doxepin Hydrochloride", "product_id": "0904-7055_b96f2236-46f3-47c4-a658-aa3d30f56b0c", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "0904-7055", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA207482", "marketing_category": "ANDA", "marketing_start_date": "20170628", "listing_expiration_date": "20261231"}