imipramine hydrochloride

Generic: imipramine hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

imipramine hydrochloride 25 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1564
Product ID 67046-1564_48e8b30a-0294-a5ed-e063-6394a90a8f01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040903
Listing Expiration 2027-12-31
Marketing Start 2026-01-21

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461564
Hyphenated Format 67046-1564

Supplemental Identifiers

RxCUI
835564
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
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1564-3)
source: ndc

Packages (1)

67046-1564-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1564-3)

Ingredients (1)

imipramine hydrochloride (25 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": "48e8b30a-0294-a5ed-e063-6394a90a8f01", "openfda": {"unii": ["BKE5Q1J60U"], "rxcui": ["835564"], "spl_set_id": ["48e8b819-a9a0-aa5a-e063-6394a90ad9c2"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1564-3)", "package_ndc": "67046-1564-3", "marketing_start_date": "20260121"}], "brand_name": "Imipramine Hydrochloride", "product_id": "67046-1564_48e8b30a-0294-a5ed-e063-6394a90a8f01", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "67046-1564", "generic_name": "Imipramine Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipramine Hydrochloride", "active_ingredients": [{"name": "IMIPRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040903", "marketing_category": "ANDA", "marketing_start_date": "20260121", "listing_expiration_date": "20271231"}