imipramine hydrochloride

Generic: imipramine hydrochloride

Labeler: oxford pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imipramine hydrochloride
Generic Name imipramine hydrochloride
Labeler oxford pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

imipramine hydrochloride 50 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-427
Product ID 69584-427_1509ebac-0e7d-4b02-ba2e-bf188a26fd77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040751
Listing Expiration 2027-12-31
Marketing Start 2020-08-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69584427
Hyphenated Format 69584-427

Supplemental Identifiers

RxCUI
835564 835568 835593
UNII
BKE5Q1J60U

Packaging Origin

Original Packager
true

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 imipramine hydrochloride (source: ndc)
Generic Name imipramine hydrochloride (source: ndc)
Application Number ANDA040751 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69584-427-10)
  • 1000 TABLET in 1 BOTTLE (69584-427-90)
source: ndc

Packages (2)

69584-427-10 100 TABLET in 1 BOTTLE (69584-427-10) 69584-427-90 1000 TABLET in 1 BOTTLE (69584-427-90)

Ingredients (1)

imipramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Imipramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1509ebac-0e7d-4b02-ba2e-bf188a26fd77", "openfda": {"unii": ["BKE5Q1J60U"], "rxcui": ["835564", "835568", "835593"], "spl_set_id": ["a5f60cf1-6f14-40a3-a794-9d69b28088d8"], "manufacturer_name": ["Oxford Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69584-427-10)", "package_ndc": "69584-427-10", "marketing_start_date": "20200801"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69584-427-90)", "package_ndc": "69584-427-90", "marketing_start_date": "20220515"}], "brand_name": "Imipramine Hydrochloride", "product_id": "69584-427_1509ebac-0e7d-4b02-ba2e-bf188a26fd77", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "69584-427", "generic_name": "Imipramine Hydrochloride", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipramine Hydrochloride", "active_ingredients": [{"name": "IMIPRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA040751", "marketing_category": "ANDA", "marketing_start_date": "20200801", "listing_expiration_date": "20271231"}