Cyproheptadine Hydrochloride Solution
NDC Package 58657-697-16

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 (cyproheptadine hydrochloride) solution is perennial and seasonal allergic rhinitisVasomotor rhinitisAllergic conjunctivitis due to inhalant allergens and foodsMild, uncomplicated allergic skin manifestations of urticaria and angioedemaAmelioration of allergic reactions to blood or plasmaCold urticariaDermatographismAs therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled. This formulation utilizes a solution delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-697 and is authorized under FDA application ANDA209108.

Identification & Billing

NDC Package Code
58657-697-16
Package Description
473 mL in 1 BOTTLE, GLASS
Product Code
58657-697
11-Digit Billing Format
58657069716
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 Solution
Non-Proprietary Name
Cyproheptadine Hydrochloride
Substance Name
Cyproheptadine
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 2 mg/5mL
Usage Information
Perennial and seasonal allergic rhinitisVasomotor rhinitisAllergic conjunctivitis due to inhalant allergens and foodsMild, uncomplicated allergic skin manifestations of urticaria and angioedemaAmelioration of allergic reactions to blood or plasmaCold urticariaDermatographismAs therapy for anaphylactic reactions adjunctiveto epinephrine and other standard measures after the acute manifestations have been controlled.

Regulatory & Marketing

Labeler Name
Method Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209108
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2024
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 58657-697-16 identifies a specific commercial package of 473 ml in 1 bottle, glass of Cyproheptadine Hydrochloride Solution, a human prescription drug labeled by Method Pharmaceuticals, Llc. This solution is formulated for oral use and contains cyproheptadine 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 Method Pharmaceuticals, Llc on June 15, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657069716. 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)
58657-697-16
11-Digit CMS (5-4-2)
58657-0697-16

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