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  5. NDC Package Code: 70518-1221-0 Potassium Citrate Extended Release

NDC Package 70518-1221-0 Potassium Citrate Extended Release

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
70518-1221-0
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
70518-1221
Proprietary Name:
Potassium Citrate Extended Release
Usage Information:
Potassium citrate extended-release tablets are contraindicated:• In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride). • In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.• In patients with peptic ulcer disease because of its ulcerogenic potential.• In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium citrate extended – release tablets to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate therapy might promote further bacterial growth.• In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.
11-Digit NDC Billing Format:
70518122100
Labeler Name:
Remedyrepack Inc.
Sample Package:
No
FDA Application Number:
ANDA206813
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-21-2018
End Marketing Date:
08-25-2022
Listing Expiration Date:
08-25-2022
Exclude Flag:
D
Code Structure:

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.

Frequently Asked Questions

What is NDC 70518-1221-0?

The NDC Packaged Code 70518-1221-0 is assigned to a package of 100 tablet in 1 bottle, plastic of Potassium Citrate Extended Release, labeled by Remedyrepack Inc.. The product's dosage form is and is administered via form.

Is NDC 70518-1221 included in the NDC Directory?

No, Potassium Citrate Extended Release with product code 70518-1221 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Remedyrepack Inc. on May 21, 2018 and its listing in the NDC Directory is set to expire on August 25, 2022 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 70518-1221-0?

The 11-digit format is 70518122100. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-170518-1221-05-4-270518-1221-00