Oracit Solution
NDC Package 46287-014-01

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

Oracit (citric acid and sodium citrate) solution is a medication used to make the urine less acidic. This formulation utilizes a solution delivery system. Marketed by Cmp Pharma, Inc., this product is identified by NDC 46287-014.

Identification & Billing

NDC Package Code
46287-014-01
Package Description
500 mL in 1 BOTTLE
Product Code
46287-014
11-Digit Billing Format
46287001401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
500 ML
RxNorm Crosswalk
  • RxCUI: 544550 - citric acid 640 MG / sodium citrate 490 MG in 5 mL Oral Solution
  • RxCUI: 544550 - citric acid 128 MG/ML / sodium citrate 98 MG/ML Oral Solution
  • RxCUI: 544550 - citric acid 640 MG / sodium citrate 490 MG per 5 ML Oral Solution
  • RxCUI: 544553 - Oracit 640 MG / 490 MG in 5 mL Oral Solution
  • RxCUI: 544553 - citric acid 128 MG/ML / sodium citrate 98 MG/ML Oral Solution [Oracit]

Clinical Specifications

Proprietary Name
Oracit
Non-Proprietary Name
Citric Acid And Sodium Citrate
Substance Name
Citric Acid Monohydrate; Trisodium Citrate Dihydrate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is used to make the urine less acidic. Urine that is less acidic helps the kidneys get rid of uric acid, helping to prevent gout and certain types of kidney stones (urate). This medication can also prevent and treat certain metabolic problems (acidosis) caused by kidney disease. Citric acid and citrate salts (which contain potassium and sodium) belong to a class of drugs known as urinary alkalinizers. Because some conditions require you to limit your intake of potassium and sodium, your doctor's choice of product may depend on how much potassium and sodium you can take.

Regulatory & Marketing

Labeler Name
Cmp Pharma, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-15-1984
Listing Expiration
12-31-2026
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 (46287-014). Click a package code to view its specific billing and regulatory data.

46287-014-15
10 BOTTLE, UNIT-DOSE in 1 CARTON / 15 mL in 1 BOTTLE, UNIT-DOSE
46287-014-30
10 BOTTLE, UNIT-DOSE in 1 CARTON / 30 mL in 1 BOTTLE, UNIT-DOSE

* 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 46287-014-01 identifies a specific commercial package of 500 ml in 1 bottle of Oracit, a human prescription drug labeled by Cmp Pharma, Inc.. This solution is formulated for oral use and contains citric acid monohydrate; trisodium citrate dihydrate 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 Cmp Pharma, Inc. on May 15, 1984. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to make the urine less acidic. Urine that is less acidic helps the kidneys get rid of uric acid, helping to prevent gout and certain types of kidney stones (urate). This medication can also prevent and treat certain metabolic problems (acidosis) caused by kidney disease. Citric acid and citrate salts (which contain potassium and sodium) belong to a class of drugs known as urinary alkalinizers. Because some conditions require you to limit your intake of potassium and sodium, your doctor's choice of product may depend on how much potassium and sodium you can take.

How is this Cmp Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46287001401. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 500 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)
46287-014-01
11-Digit CMS (5-4-2)
46287-0014-01

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