Chlorpromazine Hydrochloride Tablet, Film Coated
NDC Package 69238-1060-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Chlorpromazine Hydrochloride tablets is for the management of manifestations of psychotic disorders.For the treatment of schizophrenia.To control nausea and vomiting.For relief of restlessness and apprehension before surgery.For acute intermittent porphyria.As an adjunct in the treatment of tetanus.To control the manifestations of the manic type of manic-depressive illness.For relief of intractable hiccups. This formulation utilizes a tablet, film coated delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-1060 and is authorized under FDA application ANDA209755.

Identification & Billing

NDC Package Code
69238-1060-1
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
69238-1060
11-Digit Billing Format
69238106001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Chlorpromazine Hydrochloride
Non-Proprietary Name
Chlorpromazine Hydrochloride
Substance Name
Chlorpromazine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHLORPROMAZINE HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Usage Information
For the management of manifestations of psychotic disorders.For the treatment of schizophrenia.To control nausea and vomiting.For relief of restlessness and apprehension before surgery.For acute intermittent porphyria.As an adjunct in the treatment of tetanus.To control the manifestations of the manic type of manic-depressive illness.For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209755
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-12-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69238-1060-1 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Chlorpromazine Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This tablet, film coated is formulated for oral use and contains chlorpromazine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Ny Llc on September 12, 2018. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238106001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
69238-1060-1
11-Digit CMS (5-4-2)
69238-1060-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.