NDC Package 10135-698-01 Clomipramine Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

10135-698-01

Package Description:

100 CAPSULE in 1 BOTTLE

Product Code:

10135-698

Proprietary Name:

Clomipramine Hydrochloride

Usage Information:

Clomipramine hydrochloride capsules USP 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:

10135069801

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: 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

Labeler Name:

Marlex Pharmaceuticals Inc

Sample Package:

Start Marketing Date:

05-01-2020

Listing Expiration Date:

12-31-2022

Exclude Flag:

Code Structure:

10135 - Marlex Pharmaceuticals Inc
- 10135-698 - Clomipramine Hydrochloride
  - 10135-698-01 - 100 CAPSULE in 1 BOTTLE

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.

Frequently Asked Questions

What is NDC 10135-698-01?

The NDC Packaged Code 10135-698-01 is assigned to a package of 100 capsule in 1 bottle of Clomipramine Hydrochloride, labeled by Marlex Pharmaceuticals Inc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

Is NDC 10135-698 included in the NDC Directory?

No, Clomipramine Hydrochloride with product code 10135-698 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Marlex Pharmaceuticals Inc on May 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 10135-698-01?

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 10135-698-01?

The 11-digit format is 10135069801. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	10135-698-01	5-4-2	10135-0698-01

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