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 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-220
Product ID 72789-220_2ad0418c-56c4-50a0-e063-6394a90a35ca
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 72789220
Hyphenated Format 72789-220

Supplemental Identifiers

RxCUI
1000048
UPC
0372789220307
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
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-90)
source: ndc

Packages (2)

72789-220-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-30) 72789-220-90 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-90)

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": "2ad0418c-56c4-50a0-e063-6394a90a35ca", "openfda": {"upc": ["0372789220307"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048"], "spl_set_id": ["2bf7d838-6274-4d8a-91cb-b27e1e81d273"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-30)", "package_ndc": "72789-220-30", "marketing_start_date": "20211222"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-90)", "package_ndc": "72789-220-90", "marketing_start_date": "20240906"}], "brand_name": "Doxepin Hydrochloride", "product_id": "72789-220_2ad0418c-56c4-50a0-e063-6394a90a35ca", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72789-220", "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": "10 mg/1"}], "application_number": "ANDA211603", "marketing_category": "ANDA", "marketing_start_date": "20190327", "listing_expiration_date": "20261231"}