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  5. NDC Package Code: 47335-410-83 Sumatriptan And Naproxen Sodium

NDC Package 47335-410-83 Sumatriptan And Naproxen Sodium

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
47335-410-83
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
47335-410
Proprietary Name:
Sumatriptan And Naproxen Sodium
Non-Proprietary Name:
Sumatriptan And Naproxen Sodium
Substance Name:
Naproxen Sodium; Sumatriptan Succinate
Usage Information:
Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults.Limitations of Use:Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets  are administered to treat any subsequent attacks.Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks.Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.Pediatric use information for patients ages 12 to 17 years is approved for Pernix Ireland Ltd.’s TREXIMET® (sumatriptan and naproxen sodium) Tablets. However, due to Pernix Ireland Ltd.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
11-Digit NDC Billing Format:
47335041083
NDC to RxNorm Crosswalk:
  • RxCUI: 849450 - SUMAtriptan 85 MG / naproxen sodium 500 MG Oral Tablet
  • RxCUI: 849450 - naproxen sodium 500 MG / sumatriptan 85 MG Oral Tablet
  • RxCUI: 849450 - naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    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.
    • Active Ingredient(s):
  • NAPROXEN SODIUM 500 mg/1
  • SUMATRIPTAN SUCCINATE 85 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Serotonin 1b Receptor Agonists - [MoA] (Mechanism of Action)
  • Serotonin 1d Receptor Agonists - [MoA] (Mechanism of Action)
  • Serotonin-1b and Serotonin-1d Receptor Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202803
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-20-2018
    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
    47335-410-229 TABLET, FILM COATED in 1 BOTTLE
    47335-410-88100 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 47335-410-83?

    The NDC Packaged Code 47335-410-83 is assigned to a package of 30 tablet, film coated in 1 bottle of Sumatriptan And Naproxen Sodium, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 47335-410 included in the NDC Directory?

    Yes, Sumatriptan And Naproxen Sodium with product code 47335-410 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on July 20, 2018 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 47335-410-83?

    The 11-digit format is 47335041083. 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
    5-3-247335-410-835-4-247335-0410-83