NDC Compounded Drug 71266-8310-1 Phenylephrine Hydrochloride; Tropicamide

Solution Ophthalmic

Table of Contents

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

Compounded Drug Product Information

NDC Product Code 71266-8310
NDC Package Code 71266-8310-1
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.		 71266831001
Package Description 1 mL in 1 BOTTLE, DROPPER
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.		 Tropicamide 1%, Phenylephrine 2.5%
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.		 Tropicamide 1%, Phenylephrine 2.5%
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; 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 71266
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Fagron Compounding Services Llc Dba Fagron Sterile Services Llc Dba Jcb Laboratories
Substance Name Phenylephrine Hydrochloride; Tropicamide
Active Ingredients Information 25 mg/1 mL; 10 mg/1 mL
Reporting Period 2023-2

NDC Crossover Products Matching Phenylephrine Hydrochloride; Tropicamide

NDC crossover of Tropicamide 1%, Phenylephrine 2.5% with NDC 71266-8310 a human compounded drug with other similar products matching the same substance name (Phenylephrine Hydrochloride; Tropicamide) and the same administration route (ophthalmic) or dosage form (solution).

Frequently Asked Questions

What is the NDC number assigned to Tropicamide, Phenylephrine Hcl?

Tropicamide, Phenylephrine Hcl was assigned by its manufacturer with NDC product code 71266-8310. 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, Phenylephrine Hcl?

The NDC package code 71266-8310-1 was assigned to a 1 mL in 1 BOTTLE, DROPPER of phenylephrine hydrochloride; tropicamide administered ophthalmic via solution.

Who manufactures this product?

Tropicamide, Phenylephrine Hcl is manufactured by an outsourced facility and labeled by Fagron Compounding Services Llc Dba Fagron Sterile Services Llc Dba Jcb Laboratories. 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 2 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by OSRX, Inc. with NDC product codes 83826-9057-2 and 83826-9057-2.