imipramine hydrochloride

Generic: imipramine hydrochloride

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imipramine hydrochloride
Generic Name imipramine hydrochloride
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

imipramine hydrochloride 10 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0294
Product ID 80425-0294_2a9bad62-b304-697c-e063-6294a90aa395
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040903
Listing Expiration 2026-12-31
Marketing Start 2023-04-04

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250294
Hyphenated Format 80425-0294

Supplemental Identifiers

RxCUI
835593
UNII
BKE5Q1J60U

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 ANDA040903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0294-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0294-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0294-3)
source: ndc

Packages (3)

80425-0294-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0294-1) 80425-0294-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0294-2) 80425-0294-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0294-3)

Ingredients (1)

imipramine hydrochloride (10 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": "2a9bad62-b304-697c-e063-6294a90aa395", "openfda": {"unii": ["BKE5Q1J60U"], "rxcui": ["835593"], "spl_set_id": ["f887062a-7c82-664f-e053-6294a90a2773"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0294-1)", "package_ndc": "80425-0294-1", "marketing_start_date": "20230404"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0294-2)", "package_ndc": "80425-0294-2", "marketing_start_date": "20230404"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0294-3)", "package_ndc": "80425-0294-3", "marketing_start_date": "20230404"}], "brand_name": "Imipramine hydrochloride", "product_id": "80425-0294_2a9bad62-b304-697c-e063-6294a90aa395", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "80425-0294", "generic_name": "Imipramine hydrochloride", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipramine hydrochloride", "active_ingredients": [{"name": "IMIPRAMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA040903", "marketing_category": "ANDA", "marketing_start_date": "20230404", "listing_expiration_date": "20261231"}