doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2452
Product ID 71335-2452_34b2b0a0-565f-46cf-bd8c-c0b6902f3c8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215113
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352452
Hyphenated Format 71335-2452

Supplemental Identifiers

RxCUI
1000048
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 ANDA215113 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-1)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-2)
  • 18 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-3)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-4)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-5)
source: ndc

Packages (5)

71335-2452-1 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-1) 71335-2452-2 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-2) 71335-2452-3 18 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-3) 71335-2452-4 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-4) 71335-2452-5 180 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-5)

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": "34b2b0a0-565f-46cf-bd8c-c0b6902f3c8f", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000048"], "spl_set_id": ["efcae0f7-3491-470f-beea-1aff22178243"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-1)", "package_ndc": "71335-2452-1", "marketing_start_date": "20240820"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-2)", "package_ndc": "71335-2452-2", "marketing_start_date": "20240820"}, {"sample": false, "description": "18 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-3)", "package_ndc": "71335-2452-3", "marketing_start_date": "20240820"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-4)", "package_ndc": "71335-2452-4", "marketing_start_date": "20240820"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-5)", "package_ndc": "71335-2452-5", "marketing_start_date": "20240820"}], "brand_name": "Doxepin Hydrochloride", "product_id": "71335-2452_34b2b0a0-565f-46cf-bd8c-c0b6902f3c8f", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "71335-2452", "generic_name": "Doxepin Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA215113", "marketing_category": "ANDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}