Chlorpromazine Hydrochloride Concentrate
NDC Package 71656-101-08

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

Package Information

Chlorpromazine Hydrochloride concentrates 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.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. This formulation utilizes a concentrate delivery system. Marketed by Saptalis Pharmaceuticals, Llc., this product is identified by NDC 71656-101 and is authorized under FDA application ANDA080983.

Identification & Billing

NDC Package Code
71656-101-08
Package Description
240 mL in 1 BOTTLE, PLASTIC
Product Code
71656-101
11-Digit Billing Format
71656010108
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
RxNorm Crosswalk
  • RxCUI: 991053 - chlorproMAZINE HCl 100 MG/mL Oral Solution
  • RxCUI: 991053 - chlorpromazine hydrochloride 100 MG/ML Oral Solution
  • RxCUI: 991332 - chlorproMAZINE hydrochloride 30 MG/mL Oral Solution
  • RxCUI: 991332 - chlorpromazine hydrochloride 30 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Chlorpromazine Hydrochloride
Non-Proprietary Name
Chlorpromazine Hydrochloride
Substance Name
Chlorpromazine Hydrochloride
Dosage Form
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHLORPROMAZINE HYDROCHLORIDE 100 mg/mL
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
Saptalis Pharmaceuticals, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA080983
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-04-2026
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 71656-101-08 identifies a specific commercial package of 240 ml in 1 bottle, plastic of Chlorpromazine Hydrochloride, a human prescription drug labeled by Saptalis Pharmaceuticals, Llc.. This product is billed per "ML" milliliter and contains an estimated amount of 240 billable units per package. This concentrate 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 Saptalis Pharmaceuticals, Llc. on March 04, 2026. The current certification is valid through December 31, 2027.

How is this Saptalis Pharmaceuticals, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71656010108. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 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 (5-3-2)
71656-101-08
11-Digit CMS (5-4-2)
71656-0101-08

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