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  5. NDC Package Code: 49884-366-09 Ibuprofen And Famotidine

NDC Package 49884-366-09 Ibuprofen And Famotidine

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

Table of Contents

    1. Package Information
    2. 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:
49884-366-09
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
49884-366
Proprietary Name:
Ibuprofen And Famotidine
Non-Proprietary Name:
Ibuprofen And Famotidine
Substance Name:
Famotidine; Ibuprofen
Usage Information:
Ibuprofen and famotidine tablets, 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:
49884036609
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:
    Par Pharmaceutical, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FAMOTIDINE 26.6 mg/1
  • IBUPROFEN 800 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Histamine H2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203658
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-22-2024
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 49884-366-09?

    The NDC Packaged Code 49884-366-09 is assigned to a package of 90 tablet in 1 bottle of Ibuprofen And Famotidine, a human prescription drug labeled by Par Pharmaceutical, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 49884-366 included in the NDC Directory?

    Yes, Ibuprofen And Famotidine with product code 49884-366 is active and included in the NDC Directory. The product was first marketed by Par Pharmaceutical, Inc. on March 22, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 49884-366-09?

    The 11-digit format is 49884036609. 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
    5-3-249884-366-095-4-249884-0366-09