Allopurinol Tablet
NDC Package 48433-002-20

11-digit billing NDC: 48433000220 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Allopurinol tablets are indicated for:The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levelsThe management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables)Limitations of UseAllopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia. This formulation utilizes a tablet delivery system. Marketed by Safecor Health, Llc, this product is identified by NDC 48433-002 and is authorized under FDA application ANDA018659.

Identification & Billing

NDC Package Code
48433-002-20
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (48433-002-01)
Product Code
48433-002
11-Digit Billing Format
48433000220
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 100 mg/1
Pharmacologic Class
Usage Information
Allopurinol tablets are indicated for:The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levelsThe management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables)Limitations of UseAllopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia.

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 48433-002-20 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet in 1 blister pack (48433-002-01) 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433000220. 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)
48433-002-20
11-Digit CMS (5-4-2)
48433-0002-20

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