NDC Package 67877-626-05 Ibuprofen And Famotidine

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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:
67877-626-05
Package Description:
500 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Ibuprofen And Famotidine
Non-Proprietary Name:
Ibuprofen And Famotidine
Substance Name:
Famotidine; Ibuprofen
Usage Information:
Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies (14), Use in Specific Populations (8.5)].
11-Digit NDC Billing Format:
67877062605
NDC to RxNorm Crosswalk:
  • RxCUI: 1100066 - ibuprofen 800 MG / famotidine 26.6 MG Oral Tablet
  • RxCUI: 1100066 - famotidine 26.6 MG / ibuprofen 800 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ascend Laboratories, Llc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA211890
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-04-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    67877-626-01100 TABLET, FILM COATED in 1 BOTTLE
    67877-626-066 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
    67877-626-9090 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 67877-626-05?

    The NDC Packaged Code 67877-626-05 is assigned to a package of 500 tablet, film coated in 1 bottle of Ibuprofen And Famotidine, a human prescription drug labeled by Ascend Laboratories, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 67877-626 included in the NDC Directory?

    Yes, Ibuprofen And Famotidine with product code 67877-626 is active and included in the NDC Directory. The product was first marketed by Ascend Laboratories, Llc on August 04, 2021 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 67877-626-05?

    The 11-digit format is 67877062605. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-267877-626-055-4-267877-0626-05