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  5. NDC Package Code: 61621-430-11 Dsuvia

NDC Package 61621-430-11 Dsuvia

Sufentanil Tablet Sublingual - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find 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:
61621-430-11
Package Description:
10 TABLET in 1 CARTON
Product Code:
61621-430
Proprietary Name:
Dsuvia
Non-Proprietary Name:
Sufentanil
Substance Name:
Sufentanil
Usage Information:
DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: • Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. • Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied.  • Only to be administered by a healthcare provider. • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.4) ], reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:         - Have not been tolerated, or are not expected to be tolerated,         - Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
11-Digit NDC Billing Format:
61621043011
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Acelrx Pharmaceuticals, Inc.
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Sublingual - Administration beneath the tongue.
Active Ingredient(s):
SUFENTANIL 30 ug/1
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
NDA209128
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
11-02-2018
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
61621-430-011 TABLET in 1 POUCH

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61621-430-11?

The NDC Packaged Code 61621-430-11 is assigned to a package of 10 tablet in 1 carton of Dsuvia, a human prescription drug labeled by Acelrx Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via sublingual form.This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package.

Is NDC 61621-430 included in the NDC Directory?

Yes, Dsuvia with product code 61621-430 is active and included in the NDC Directory. The product was first marketed by Acelrx Pharmaceuticals, Inc. on November 02, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61621-430-11?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 10.

What is the 11-digit format for NDC 61621-430-11?

The 11-digit format is 61621043011. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-261621-430-115-4-261621-0430-11