Glycopyrrolate Injection, Solution
NDC Package 76045-203-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Glycopyrrolate injection is glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 76045-203 and is authorized under FDA application ANDA209024.

Identification & Billing

NDC Package Code
76045-203-20
Package Description
24 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02) / 2 mL in 1 SYRINGE, GLASS
Product Code
76045-203
11-Digit Billing Format
76045020320
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glycopyrrolate
Non-Proprietary Name
Glycopyrrolate
Substance Name
Glycopyrrolate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GLYCOPYRROLATE .2 mg/mL
Pharmacologic Class
Usage Information
Glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Glycopyrrolate works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209024
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-25-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1596
Source: PDAC
INJECTION, GLYCOPYRROLATE, 0.1 MG
HCPCS Dosage 0.1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76045-203). Click a package code to view its specific billing and regulatory data.

76045-203-10
24 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01) / 1 mL in 1 SYRINGE, GLASS

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76045-203-20 identifies a specific commercial package of 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack (76045-203-02) / 2 ml in 1 syringe, glass of Glycopyrrolate, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for intramuscular; intravenous use and contains glycopyrrolate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on July 25, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Glycopyrrolate works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76045020320. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76045-203-20
11-Digit CMS (5-4-2)
76045-0203-20

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.