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 72789-542
Product ID 72789-542_463de429-bc73-951e-e063-6394a90add02
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 72789542
Hyphenated Format 72789-542

Supplemental Identifiers

RxCUI
1000070
UPC
0372789542300
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
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-542-30)
source: ndc

Packages (1)

72789-542-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-542-30)

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": "463de429-bc73-951e-e063-6394a90add02", "openfda": {"upc": ["0372789542300"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000070"], "spl_set_id": ["1496dfc1-de50-471c-be87-1f1e2b70ab5a"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-542-30)", "package_ndc": "72789-542-30", "marketing_start_date": "20251218"}], "brand_name": "Doxepin Hydrochloride", "product_id": "72789-542_463de429-bc73-951e-e063-6394a90add02", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72789-542", "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": "ANDA211603", "marketing_category": "ANDA", "marketing_start_date": "20190327", "listing_expiration_date": "20261231"}