Dsuvia Tablet
NDC Package 61621-430-01

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Dsuvia (sufentanil) tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Acelrx Pharmaceuticals, Inc., this product is identified by NDC 61621-430 and is authorized under FDA application NDA209128.

Identification & Billing

NDC Package Code
61621-430-01
Package Description
1 TABLET in 1 POUCH
Product Code
61621-430
11-Digit Billing Format
61621043001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dsuvia
Non-Proprietary Name
Sufentanil
Substance Name
Sufentanil
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
SUFENTANIL 30 ug/1
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Acelrx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA209128
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-02-2018
End Marketing Date
07-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61621-430). Click a package code to view its specific billing and regulatory data.

61621-430-11
10 TABLET in 1 CARTON

* 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 61621-430-01 identifies a specific commercial package of 1 tablet in 1 pouch of Dsuvia, a human prescription drug labeled by Acelrx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for sublingual use and contains sufentanil 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 Acelrx Pharmaceuticals, Inc. on November 02, 2018.

How is this Acelrx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61621043001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
61621-430-01
11-Digit CMS (5-4-2)
61621-0430-01

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