NDC Package 0065-0395-15 Cyclogyl

Cyclopentolate Hydrochloride Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0065-0395-15

Package Description:

1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC

Product Code:

0065-0395

Proprietary Name:

Cyclogyl

Non-Proprietary Name:

Cyclopentolate Hydrochloride

Substance Name:

Cyclopentolate Hydrochloride

Usage Information:

This medication is used before eye examinations (e.g., refraction exams). It belongs to a class of drugs known as anticholinergics. Cyclopentolate works by temporarily widening (dilating) the pupil of the eye and relaxing the muscles of the eye.

11-Digit NDC Billing Format:

00065039515

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 1298066 - cyclopentolate HCl 1 % Ophthalmic Solution

RxCUI: 1298066 - cyclopentolate hydrochloride 10 MG/ML Ophthalmic Solution

RxCUI: 1298066 - cyclopentolate hydrochloride 1 % Ophthalmic Solution

RxCUI: 1298070 - cyclopentolate HCl 2 % Ophthalmic Solution

RxCUI: 1298070 - cyclopentolate hydrochloride 20 MG/ML Ophthalmic Solution

Product Type:

Human Prescription Drug

Labeler Name:

Alcon Laboratories, Inc.

Dosage Form:

Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Administration Route(s):

Ophthalmic - Administration to the external eye.

Active Ingredient(s):

CYCLOPENTOLATE HYDROCHLORIDE 5 mg/mL

Sample Package:

FDA Application Number:

ANDA084109

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

10-15-1975

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0065 - Alcon Laboratories, Inc.
- 0065-0395 - Cyclogyl
  - 0065-0395-15 - 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC

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 disclaimer below.

Frequently Asked Questions

What is NDC 0065-0395-15?

The NDC Packaged Code 0065-0395-15 is assigned to a package of 1 bottle, plastic in 1 carton / 15 ml in 1 bottle, plastic of Cyclogyl, a human prescription drug labeled by Alcon Laboratories, Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Is NDC 0065-0395 included in the NDC Directory?

Yes, Cyclogyl with product code 0065-0395 is active and included in the NDC Directory. The product was first marketed by Alcon Laboratories, Inc. on October 15, 1975 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0065-0395-15?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 0065-0395-15?

The 11-digit format is 00065039515. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0065-0395-15	5-4-2	00065-0395-15

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