Allopurinol Tablet
NDC Package 48433-003-20

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

Package Information

Allopurinol tablets is allopurinol is used to treat gout and certain types of kidney stones. This formulation utilizes a tablet delivery system. Marketed by Safecor Health, Llc, this product is identified by NDC 48433-003 and is authorized under FDA application ANDA018659.

Identification & Billing

NDC Package Code
48433-003-20
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (48433-003-01)
Product Code
48433-003
11-Digit Billing Format
48433000320
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Allopurinol
Non-Proprietary Name
Allopurinol
Substance Name
Allopurinol
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALLOPURINOL 300 mg/1
Pharmacologic Class
Usage Information
Allopurinol is used to treat gout and certain types of kidney stones. It is also used to prevent increased uric acid levels in patients receiving cancer chemotherapy. These patients can have increased uric acid levels due to release of uric acid from the dying cancer cells. Allopurinol works by reducing the amount of uric acid made by the body. Increased uric acid levels can cause gout and kidney problems.

Regulatory & Marketing

Labeler Name
Safecor Health, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA018659
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-19-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48433-003-20 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet in 1 blister pack (48433-003-01) of Allopurinol, a human prescription drug labeled by Safecor Health, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains allopurinol 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 Safecor Health, Llc on March 19, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Allopurinol is used to treat gout and certain types of kidney stones. It is also used to prevent increased uric acid levels in patients receiving cancer chemotherapy. These patients can have increased uric acid levels due to release of uric acid from the dying cancer cells. Allopurinol works by reducing the amount of uric acid made by the body. Increased uric acid levels can cause gout and kidney problems.

How is this Safecor Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433000320. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
48433-003-20
11-Digit CMS (5-4-2)
48433-0003-20

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