doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5179
Product ID 68071-5179_1b569e5e-9af4-79a6-e063-6394a90a1647
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211603
Listing Expiration 2026-12-31
Marketing Start 2019-03-27

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680715179
Hyphenated Format 68071-5179

Supplemental Identifiers

RxCUI
1000048
UPC
0368071517996
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 ANDA211603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (68071-5179-9)
source: ndc

Packages (1)

68071-5179-9 90 CAPSULE in 1 BOTTLE (68071-5179-9)

Ingredients (1)

doxepin hydrochloride (10 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": "1b569e5e-9af4-79a6-e063-6394a90a1647", "openfda": {"upc": ["0368071517996"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048"], "spl_set_id": ["9ee26b24-7121-3107-e053-2995a90ac61c"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68071-5179-9)", "package_ndc": "68071-5179-9", "marketing_start_date": "20200218"}], "brand_name": "Doxepin Hydrochloride", "product_id": "68071-5179_1b569e5e-9af4-79a6-e063-6394a90a1647", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "68071-5179", "generic_name": "Doxepin Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA211603", "marketing_category": "ANDA", "marketing_start_date": "20190327", "listing_expiration_date": "20261231"}