doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

doxepin hydrochloride 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-334
Product ID 72789-334_436c46ab-0e41-2983-e063-6394a90ad90d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213474
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789334
Hyphenated Format 72789-334

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0372789336305 0372789333014 0372789335308 0372789337302 0372789334301
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 ANDA213474 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-334-30)
source: ndc

Packages (1)

72789-334-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-334-30)

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": "436c46ab-0e41-2983-e063-6394a90ad90d", "openfda": {"upc": ["0372789336305", "0372789333014", "0372789335308", "0372789337302", "0372789334301"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["8f7e9677-cc84-414b-8eb8-33993d285bb3"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-334-30)", "package_ndc": "72789-334-30", "marketing_start_date": "20230728"}], "brand_name": "Doxepin Hydrochloride", "product_id": "72789-334_436c46ab-0e41-2983-e063-6394a90ad90d", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72789-334", "generic_name": "Doxepin Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxepin Hydrochloride", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA213474", "marketing_category": "ANDA", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}