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 55289-370
Product ID 55289-370_47e38717-0379-0f31-e063-6394a90a1baf
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 55289370
Hyphenated Format 55289-370

Supplemental Identifiers

RxCUI
1000070
UPC
0355289370307
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
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-90)
source: ndc

Packages (2)

55289-370-30 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-30) 55289-370-90 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-90)

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": "47e38717-0379-0f31-e063-6394a90a1baf", "openfda": {"upc": ["0355289370307"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000070"], "spl_set_id": ["1ede17e6-19e9-455c-ad16-8029a590735c"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-30)", "package_ndc": "55289-370-30", "marketing_start_date": "20070802"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-90)", "package_ndc": "55289-370-90", "marketing_start_date": "20200316"}], "brand_name": "Doxepin Hydrochloride", "product_id": "55289-370_47e38717-0379-0f31-e063-6394a90a1baf", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "55289-370", "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": "ANDA070791", "marketing_category": "ANDA", "marketing_start_date": "19860513", "listing_expiration_date": "20271231"}