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  5. NDC Package Code: 69315-134-01 Imipramine Hydrochloride

NDC Package 69315-134-01 Imipramine Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69315-134-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
69315-134
Proprietary Name:
Imipramine Hydrochloride
Non-Proprietary Name:
Imipramine Hydrochloride
Substance Name:
Imipramine Hydrochloride
Usage Information:
The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of adverse effects can be serious, or even fatal. When it is desired to substitute Imipramine hydrochloride tablets, USP in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. Initial dosage should be low and increases should be gradual and cautiously prescribed.The drug is contraindicated during the acute recovery period after a myocardial infarction. Patients with a known hypersensitivity to this compound should not be given the drug. The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind.
11-Digit NDC Billing Format:
69315013401
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 835564 - imipramine HCl 25 MG Oral Tablet
  • RxCUI: 835564 - imipramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 835568 - imipramine HCl 50 MG Oral Tablet
  • RxCUI: 835568 - imipramine hydrochloride 50 MG Oral Tablet
  • RxCUI: 835593 - imipramine HCl 10 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Leading Pharma, Llc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • IMIPRAMINE HYDROCHLORIDE 25 mg/1
    • Pharmacologic Class(es):
  • Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA040903
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-07-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    69315-134-101000 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69315-134-01?

    The NDC Packaged Code 69315-134-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Imipramine Hydrochloride, a human prescription drug labeled by Leading Pharma, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 69315-134 included in the NDC Directory?

    Yes, Imipramine Hydrochloride with product code 69315-134 is active and included in the NDC Directory. The product was first marketed by Leading Pharma, Llc on April 07, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 69315-134-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 69315-134-01?

    The 11-digit format is 69315013401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-269315-134-015-4-269315-0134-01