imipramine hydrochloride

Generic: imipramine hydrochloride

Labeler: key therapeutics
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

imipramine hydrochloride 25 mg/1

Manufacturer
Key Therapeutics

Identifiers & Regulatory

Product NDC 70868-810
Product ID 70868-810_241442d6-33bd-74fe-e063-6394a90a0a49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040751
Listing Expiration 2026-12-31
Marketing Start 2022-07-18

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70868810
Hyphenated Format 70868-810

Supplemental Identifiers

RxCUI
835564
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
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70868-810-10)
source: ndc

Packages (1)

70868-810-10 100 TABLET, FILM COATED in 1 BOTTLE (70868-810-10)

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": "241442d6-33bd-74fe-e063-6394a90a0a49", "openfda": {"unii": ["BKE5Q1J60U"], "rxcui": ["835564"], "spl_set_id": ["9c685c94-64cd-442a-ade7-193c62d7a058"], "manufacturer_name": ["Key Therapeutics"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70868-810-10)", "package_ndc": "70868-810-10", "marketing_start_date": "20220718"}], "brand_name": "Imipramine Hydrochloride", "product_id": "70868-810_241442d6-33bd-74fe-e063-6394a90a0a49", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "70868-810", "generic_name": "Imipramine Hydrochloride", "labeler_name": "Key Therapeutics", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipramine Hydrochloride", "active_ingredients": [{"name": "IMIPRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040751", "marketing_category": "ANDA", "marketing_start_date": "20220718", "listing_expiration_date": "20261231"}