NDC Package 83090-010-01 Arsenic Trioxide

Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

83090-010-01

Package Description:

1 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)

Product Code:

83090-010

Proprietary Name:

Arsenic Trioxide

Non-Proprietary Name:

Arsenic Trioxide

Substance Name:

Arsenic Trioxide

Usage Information:

Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

11-Digit NDC Billing Format:

83090001001

NDC to RxNorm Crosswalk:

RxCUI: 1992545 - arsenic trioxide 12 MG in 6 ML Injection

RxCUI: 1992545 - 6 ML arsenic trioxide 2 MG/ML Injection

RxCUI: 1992545 - arsenic trioxide 12 MG per 6 ML Injection

RxCUI: 1992545 - arsenic trioxide 2 MG/ML per 6 ML Injection

RxCUI: 829926 - arsenic trioxide 10 MG in 1 ML Injection

Product Type:

Human Prescription Drug

Labeler Name:

Sintetica Us Llc

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(s):

Intravenous - Administration within or into a vein or veins.

Active Ingredient(s):

ARSENIC TRIOXIDE 2 mg/mL

Sample Package:

FDA Application Number:

ANDA217413

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

11-09-2023

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

83090 - Sintetica Us Llc
- 83090-010 - Arsenic Trioxide
  - 83090-010-01 - 1 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
83090-010-10	10 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE (83090-010-05)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 83090-010-01?

The NDC Packaged Code 83090-010-01 is assigned to a package of 1 vial, single-dose in 1 carton / 6 ml in 1 vial, single-dose (83090-010-05) of Arsenic Trioxide, a human prescription drug labeled by Sintetica Us Llc. The product's dosage form is injection, solution and is administered via intravenous form.

Is NDC 83090-010 included in the NDC Directory?

Yes, Arsenic Trioxide with product code 83090-010 is active and included in the NDC Directory. The product was first marketed by Sintetica Us Llc on November 09, 2023 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 11-digit format for NDC 83090-010-01?

The 11-digit format is 83090001001. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	83090-010-01	5-4-2	83090-0010-01

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