imipramine hydrochloride

Generic: imipramine hydrochloride

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imipramine hydrochloride
Generic Name imipramine hydrochloride
Labeler leading pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

imipramine hydrochloride 10 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-133
Product ID 69315-133_2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040903
Listing Expiration 2026-12-31
Marketing Start 2016-04-07

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315133
Hyphenated Format 69315-133

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 ANDA040903 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69315-133-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69315-133-10)
source: ndc

Packages (2)

69315-133-01 100 TABLET, FILM COATED in 1 BOTTLE (69315-133-01) 69315-133-10 1000 TABLET, FILM COATED in 1 BOTTLE (69315-133-10)

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": "2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f", "openfda": {"unii": ["BKE5Q1J60U"], "rxcui": ["835564", "835568", "835593"], "spl_set_id": ["490263ce-b4d2-428a-87da-fcd07f85499a"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69315-133-01)", "package_ndc": "69315-133-01", "marketing_start_date": "20160407"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69315-133-10)", "package_ndc": "69315-133-10", "marketing_start_date": "20160414"}], "brand_name": "Imipramine Hydrochloride", "product_id": "69315-133_2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "69315-133", "generic_name": "Imipramine Hydrochloride", "labeler_name": "Leading Pharma, 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": "20160407", "listing_expiration_date": "20261231"}