Cyproheptadine Hydrochloride Solution
NDC Package 70752-101-12

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

Package Information

Cyproheptadine Hydrochloride solution 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 DermatographismAs therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. This formulation utilizes a solution delivery system. Marketed by Quagen Pharmaceuticals Llc, this product is identified by NDC 70752-101 and is authorized under FDA application ANDA212423.

Identification & Billing

NDC Package Code
70752-101-12
Package Description
473 mL in 1 BOTTLE, GLASS
Product Code
70752-101
11-Digit Billing Format
70752010112
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyproheptadine Hydrochloride
Non-Proprietary Name
Cyproheptadine Hydrochloride
Substance Name
Cyproheptadine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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 DermatographismAs therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Regulatory & Marketing

Labeler Name
Quagen Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212423
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-22-2019
Listing Expiration
12-31-2026
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 70752-101-12 identifies a specific commercial package of 473 ml in 1 bottle, glass of Cyproheptadine Hydrochloride, a human prescription drug labeled by Quagen Pharmaceuticals Llc. This solution 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 Quagen Pharmaceuticals Llc on May 22, 2019. The current certification is valid through December 31, 2026.

How is this Quagen Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70752010112. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
70752-101-12
11-Digit CMS (5-4-2)
70752-0101-12

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