0065-0396 NDC - CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE)

Drug Information

Product NDC: 0065-0396
Proprietary Name: Cyclogyl
Non Proprietary Name: cyclopentolate hydrochloride
Active Ingredient(s): 10 mg/mL CYCLOPENTOLATE HYDROCHLORIDE
Administration Route(s): OPHTHALMIC
Dosage Form(s): SOLUTION/ DROPS

Labeler Information

Field Name	Field Value
Labeler Name:	Alcon Laboratories, Inc.
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA084110
Marketing Category:	ANDA
Start Marketing Date:	10/15/1975

Package Information

No.	Package Code	Package Description	Billing Unit
1	0065-0396-02	1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-02) / 2 mL in 1 BOTTLE, PLASTIC	ML
2	0065-0396-05	1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-05) / 5 mL in 1 BOTTLE, PLASTIC	ML
3	0065-0396-15	1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-15) / 15 mL in 1 BOTTLE, PLASTIC	ML

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0065-0396	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Cyclogyl	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
NON PROPRIETARY NAME	cyclopentolate hydrochloride	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SOLUTION/ DROPS	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
ROUTE NAME	OPHTHALMIC	This is the date that the labeler indicates was the start of its marketing of the drug product.
START MARKETING DATE	10/15/1975	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
APPLICATION NUMBER	ANDA084110	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Alcon Laboratories, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	CYCLOPENTOLATE HYDROCHLORIDE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	10
ACTIVE INGRED UNIT	mg/mL

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This page was last updated on: 12/19/2025

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