Cyproheptadine Hydrochloride Syrup
NDC Package 17856-0504-1

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

Package Information

Cyproheptadine Hydrochloride syrups is perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. This formulation utilizes a syrup delivery system. Marketed by Atlantic Biological Corp., this product is identified by NDC 17856-0504 and is authorized under FDA application ANDA040668.

Identification & Billing

NDC Package Code
17856-0504-1
Package Description
120 SYRINGE in 1 CASE / 2.5 mL in 1 SYRINGE
Product Code
17856-0504
11-Digit Billing Format
17856050401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyproheptadine Hydrochloride
Non-Proprietary Name
Cyproheptadine Hydrochloride
Substance Name
Cyproheptadine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL
Usage Information
Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Regulatory & Marketing

Labeler Name
Atlantic Biological Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA040668
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-10-2006
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 17856-0504-1 identifies a specific commercial package of 120 syringe in 1 case / 2.5 ml in 1 syringe of Cyproheptadine Hydrochloride, a human prescription drug labeled by Atlantic Biological Corp.. This syrup is formulated for oral use and contains cyproheptadine 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 Atlantic Biological Corp. on July 10, 2006. The current certification is valid through December 31, 2027.

How is this Atlantic Biological Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856050401. 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)
17856-0504-1
11-Digit CMS (5-4-2)
17856-0504-01

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