NDC Package 68210-0081-3 Assured Ibuprofen

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

68210-0081-3

Package Description:

1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

Product Code:

68210-0081

Proprietary Name:

Assured Ibuprofen

Usage Information:

Do not take more than directedthe smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in 24 hours, unless directed by a doctorchildren under 12 years: ask a doctor

11-Digit NDC Billing Format:

68210008103

NDC to RxNorm Crosswalk:

RxCUI: 310965 - ibuprofen 200 MG Oral Tablet
RxCUI: 310965 - ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet

Labeler Name:

Spirit Pharmaceutical Llc

Sample Package:

FDA Application Number:

ANDA079174

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

12-15-2017

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

68210 - Spirit Pharmaceutical Llc
- 68210-0081 - Assured Ibuprofen
  - 68210-0081-3 - 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED 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
68210-0081-6	1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68210-0081-3?

The NDC Packaged Code 68210-0081-3 is assigned to a package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Assured Ibuprofen, labeled by Spirit Pharmaceutical Llc. The product's dosage form is and is administered via form.

Is NDC 68210-0081 included in the NDC Directory?

No, Assured Ibuprofen with product code 68210-0081 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Spirit Pharmaceutical Llc on December 15, 2017 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 11-digit format for NDC 68210-0081-3?

The 11-digit format is 68210008103. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	68210-0081-3	5-4-2	68210-0081-03

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