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 72789-072
Product ID 72789-072_47a923cf-2731-8fc9-e063-6294a90afa38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070791
Listing Expiration 2027-12-31
Marketing Start 1986-05-13

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789072
Hyphenated Format 72789-072

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 ANDA070791 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-072-30)
source: ndc

Packages (1)

72789-072-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-072-30)

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": "47a923cf-2731-8fc9-e063-6294a90afa38", "openfda": {"unii": ["3U9A0FE9N5"], "rxcui": ["1000048"], "spl_set_id": ["d2a91b99-513d-4894-ad6d-02d2028a2290"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-072-30)", "package_ndc": "72789-072-30", "marketing_start_date": "20200401"}], "brand_name": "Doxepin Hydrochloride", "product_id": "72789-072_47a923cf-2731-8fc9-e063-6294a90afa38", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72789-072", "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": "ANDA070791", "marketing_category": "ANDA", "marketing_start_date": "19860513", "listing_expiration_date": "20271231"}