NDC Package 46287-014-01 Oracit

Citric Acid And Sodium Citrate Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
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:

46287-014-01

Package Description:

500 mL in 1 BOTTLE

Product Code:

46287-014

Proprietary Name:

Oracit

Non-Proprietary Name:

Citric Acid And Sodium Citrate

Substance Name:

Citric Acid Monohydrate; Trisodium Citrate Dihydrate

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.

11-Digit NDC Billing Format:

46287001401

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

500 ML

NDC to 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]

Product Type:

Human Prescription Drug

Labeler Name:

Cmp Pharma, Inc.

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

CITRIC ACID MONOHYDRATE 640 mg/5mL

TRISODIUM CITRATE DIHYDRATE 490 mg/5mL

Pharmacologic Class(es):

Acidifying Activity - [MoA] (Mechanism of Action)

Anti-coagulant - [EPC] (Established Pharmacologic Class)

Calcium Chelating Activity - [MoA] (Mechanism of Action)

Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)

Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)

Sample Package:

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 Date:

12-31-2024

Exclude Flag:

Code Structure:

46287 - Cmp Pharma, Inc.
- 46287-014 - Oracit
  - 46287-014-01 - 500 mL in 1 BOTTLE

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
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 disclaimer below.

Frequently Asked Questions

What is NDC 46287-014-01?

The NDC Packaged Code 46287-014-01 is assigned to a package of 500 ml in 1 bottle of Oracit, a human prescription drug labeled by Cmp Pharma, Inc.. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package.

Is NDC 46287-014 included in the NDC Directory?

Yes, Oracit with product code 46287-014 is active and included in the NDC Directory. The product was first marketed by Cmp Pharma, Inc. on May 15, 1984 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 46287-014-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 500.

What is the 11-digit format for NDC 46287-014-01?

The 11-digit format is 46287001401. 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	46287-014-01	5-4-2	46287-0014-01

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