NDC Compounded Drug 70092-083-44 Glycopyrrolate

Injection Intravenous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Glycopyrrolate 0.2 Mg/ml 5ml Syr
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 70092-083
NDC Package Code 70092-083-44
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.		 70092008344
Package Description 5 mL in 1 SYRINGE
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.		 Glycopyrrolate 0.2 Mg/ml 5ml Syr
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.		 Glycopyrrolate 0.2 Mg/ml 5ml Syr
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.		 Glycopyrrolate
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 Glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This medication works by decreasing the amount of saliva you make. Glycopyrrolate belongs to a class of drugs known as anticholinergics.
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Route Name Intravenous - Administration within or into a vein or veins.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 70092
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Quva Pharma, Inc.
Substance Name Glycopyrrolate
Active Ingredients Information 1 mg/5 mL
Reporting Period 2022-2

NDC Crossover Products Matching Glycopyrrolate

NDC crossover of Glycopyrrolate 0.2 Mg/ml 5ml Syr with NDC 70092-083 a human compounded drug with other similar products matching the same substance name (Glycopyrrolate) and the same administration route (intravenous) or dosage form (injection).

Frequently Asked Questions

What is the NDC number assigned to Glycopyrrolate?

Glycopyrrolate was assigned by its manufacturer with NDC product code 70092-083. 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 Glycopyrrolate?

The NDC package code 70092-083-44 was assigned to a 5 mL in 1 SYRINGE of glycopyrrolate administered intravenous via injection.

Who manufactures this product?

Glycopyrrolate is manufactured by an outsourced facility and labeled by Quva Pharma, Inc.. 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 28 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Hikma Injectables USA Inc., Fagron Compounding Services LLC dba Fagron Sterile Services LLC dba JCB Laboratories, Fresenius Kabi Compounding LLC DBA Fagron Sterile Services and Wells Pharma of Houston with NDC product codes 63037-125-25, 63037-125-25, 63037-125-25, 63037-125-25, 71266-2004-8, 71266-2004-8, 71266-2004-9, 71266-2004-9, 71266-2004-9, 71266-2004-9, 71266-9015-3, 71266-9015-3, 71266-9015-3, 71266-9015-3, 71266-9015-5, 71266-9015-5, 71266-9015-5, 71266-9015-5, 71506-023-03, 71506-023-03, 71506-023-03, 71506-023-03, 73702-109-15, 73702-109-15, 73702-109-15, 73702-109-32, 73702-109-32 and 73702-109-32.