NDC Compounded Drug 69194-608-01 Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Tropicamide

Solution Ophthalmic

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching 608 Tropicamide 1%, Phenylephrine Hcl 2.5%, Cyclopentolate Hcl 1% Bottle
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 69194-608
NDC Package Code 69194-608-01
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 69194060801
Package Description 5 mL in 1 BOTTLE
Product Type What kind of product is this?
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.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 608 Tropicamide 1%, Phenylephrine Hcl 2.5%, Cyclopentolate Hcl 1% Bottle
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		 Cyclopentolate Hcl, Phenylephrine Hcl, Tropicamide
Substance Name What is the Substance Name?
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.		 Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Tropicamide
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.
Route Name Ophthalmic - Administration to the external eye.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 69194
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Pine Pharmaceuticals Llc
Substance Name Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Tropicamide
Active Ingredients Information 25 mg/1 mL; 10 mg/1 mL; 10 mg/1 mL
Reporting Period 2024-2

NDC Crossover Products Matching Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Tropicamide

NDC crossover of 608 Tropicamide 1%, Phenylephrine Hcl 2.5%, Cyclopentolate Hcl 1% Bottle with NDC 69194-608 a human compounded drug with other similar products matching the same substance name (Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Tropicamide) and the same administration route (ophthalmic) or dosage form (solution).

Frequently Asked Questions

What is the NDC number assigned to Tropicamide 1%, Cyclopentolate 1%, Phenylephrine 2.5%?

Tropicamide 1%, Cyclopentolate 1%, Phenylephrine 2.5% was assigned by its manufacturer with NDC product code 69194-608. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Tropicamide 1%, Cyclopentolate 1%, Phenylephrine 2.5%?

The NDC package code 69194-608-01 was assigned to a 5 mL in 1 BOTTLE of phenylephrine hydrochloride; cyclopentolate hydrochloride; tropicamide administered ophthalmic via solution.

Who manufactures this product?

Tropicamide 1%, Cyclopentolate 1%, Phenylephrine 2.5% is manufactured by an outsourced facility and labeled by Pine Pharmaceuticals Llc. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 8 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Fagron Compounding Services LLC dba Fagron Sterile Services LLC dba JCB Laboratories with NDC product codes 71266-8211-1, 71266-8211-1, 71266-8211-1, 71266-8211-1, 71266-8211-5, 71266-8211-5, 71266-8211-5 and 71266-8211-5.