NDC Package 62332-409-90 Clomipramine Hydrochloride

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

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:
62332-409-90
Package Description:
90 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Clomipramine Hydrochloride
Non-Proprietary Name:
Clomipramine Hydrochloride
Substance Name:
Clomipramine Hydrochloride
Usage Information:
Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego­ dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
11-Digit NDC Billing Format:
62332040990
NDC to RxNorm Crosswalk:
  • RxCUI: 857297 - clomiPRAMINE HCl 25 MG Oral Capsule
  • RxCUI: 857297 - clomipramine hydrochloride 25 MG Oral Capsule
  • RxCUI: 857301 - clomiPRAMINE HCl 50 MG Oral Capsule
  • RxCUI: 857301 - clomipramine hydrochloride 50 MG Oral Capsule
  • RxCUI: 857305 - clomiPRAMINE HCl 75 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alembic Pharmaceuticals Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA211822
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-05-2021
    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
    62332-409-3030 CAPSULE in 1 BOTTLE
    62332-409-31100 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 62332-409-90?

    The NDC Packaged Code 62332-409-90 is assigned to a package of 90 capsule in 1 bottle of Clomipramine Hydrochloride, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 62332-409 included in the NDC Directory?

    Yes, Clomipramine Hydrochloride with product code 62332-409 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Inc. on August 05, 2021 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 11-digit format for NDC 62332-409-90?

    The 11-digit format is 62332040990. 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
    5-3-262332-409-905-4-262332-0409-90