NDC 0548-5850-00 Glucagon
Kit

Package Information
NDC HCPCS Crosswalk
Frequently Asked Questions

Package Information

The table below has all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code	0548-5850-00
Package Description	1 KIT in 1 KIT * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00)
Product Code	0548-5850
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.	Glucagon
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.	Glucagon
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.	This medication is the same as your body's own glucagon, a natural substance that raises blood sugar by causing the body to release sugar stored in the liver. It is used to treat very low blood sugar (hypoglycemia) that may cause you to need help from others. Make sure a family member or caregiver knows where you keep this medication and how to use it before you need their help.
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.	00548585000
Billing Unit	EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NADAC Wholesale Price per Unit National Average Drug Acquisition Cost (NADAC) The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 0548-5850-00 is $230.05176 and is up-to-date as of 08-30-2023. This product is billed for "EA" each discreet unit and contains an estimated amount of billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $	$230.05176
NDC to RxNorm Crosswalk	RxCUI: 310497 - glucagon (rDNA) 1 MG Injection
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 Prescription Drug
Labeler Name	Amphastar Pharmaceuticals, Inc.
Dosage Form	Kit - A packaged collection of related material.
Sample Package Sample Package? This field Indicates whether this package is a sample packaging or not.	No
Marketing Category What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.	ANDA - A product marketed under an approved Abbreviated New Drug Application.
FDA Application Number What is the FDA Application Number? 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.	ANDA208086
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	02-10-2021
Listing Expiration Date What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.	12-31-2023
Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	N
NDC Code Structure	0548 - Amphastar Pharmaceuticals, Inc. 0548-5850 - Glucagon 0548-5850-00 - 1 KIT in 1 KIT * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00)

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 disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0548-5850-00 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
00548585000	J1610	Glucagon hydrochloride/1 mg	1 MG	1	1	1	1

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0548-5850-00?

The NDC Packaged Code 0548-5850-00 is assigned to a package of 1 kit in 1 kit * 1 ml in 1 vial (0548-5905-00) * 1 ml in 1 syringe (0548-5831-00) of Glucagon, a human prescription drug labeled by Amphastar Pharmaceuticals, Inc.. The product's dosage form is kit and is administered via form.

Is NDC 0548-5850 included in the NDC Directory?

Yes, Glucagon with product code 0548-5850 is active and included in the NDC Directory. The product was first marketed by Amphastar Pharmaceuticals, Inc. on February 10, 2021 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0548-5850-00?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

What is the 11-digit format for NDC 0548-5850-00?

The 11-digit format is 00548585000. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Package Format	10-Digit Original Package Code	11-Digit Package Format	11-Digit Conversion Package Code
4-4-2	0548-5850-00	5-4-2	00548-5850-00

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