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NDC 00065-0395-15 Cyclogyl 5 mg/mL Details

Cyclogyl 5 mg/mL

Cyclogyl is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is CYCLOPENTOLATE HYDROCHLORIDE.

MedlinePlus Drug Summary

Cyclopentolate ophthalmic is used to cause mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscle of the eye) before an eye examination. Cyclopentolate is in a class of medications called mydriatics. Cyclopentolate works by blocking certain receptors found in the eye to temporarily relax or provide short-term paralysis of the eye muscles.

Related Packages: 00065-0395-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cyclopentolate Ophthalmic

Product Information

NDC	00065-0395
Product ID	0065-0395_0aa45ce5-d393-4030-aab5-ff5073c42381
Associated GPIs	86350020102005
GCN Sequence Number	007874
GCN Sequence Number Description	cyclopentolate HCl DROPS 0.5 % OPHTHALMIC
HIC3	Q6J
HIC3 Description	MYDRIATICS
GCN	33030
HICL Sequence Number	003467
HICL Sequence Number Description	CYCLOPENTOLATE HCL
Brand/Generic	Brand
Proprietary Name	Cyclogyl
Proprietary Name Suffix	n/a
Non-Proprietary Name	cyclopentolate hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	5
Active Ingredient Units	mg/mL
Substance Name	CYCLOPENTOLATE HYDROCHLORIDE
Labeler Name	Alcon Laboratories, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA084109
Listing Certified Through	2024-12-31

Package

NDC 00065-0395-15 (00065039515)

Pricing Information	N/A
NDC Package Code	0065-0395-15
Billing NDC	00065039515
Package	1 BOTTLE, PLASTIC in 1 CARTON (0065-0395-15) / 15 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	1975-10-15
NDC Exclude Flag	N