NDC Package 47335-380-83 Cinacalcet

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:
47335-380-83
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Cinacalcet
Non-Proprietary Name:
Cinacalcet
Substance Name:
Cinacalcet Hydrochloride
Usage Information:
Cinacalcet treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1)].
11-Digit NDC Billing Format:
47335038083
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 432400 - cinacalcet HCl 90 MG Oral Tablet
  • RxCUI: 432400 - cinacalcet 90 MG Oral Tablet
  • RxCUI: 432400 - cinacalcet 90 MG (as cinacalcet HCl 99 MG) Oral Tablet
  • RxCUI: 432401 - cinacalcet HCl 60 MG Oral Tablet
  • RxCUI: 432401 - cinacalcet 60 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):
    Sample Package:
    No
    FDA Application Number:
    ANDA207008
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-15-2019
    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.

    Frequently Asked Questions

    What is NDC 47335-380-83?

    The NDC Packaged Code 47335-380-83 is assigned to a package of 30 tablet, film coated in 1 bottle of Cinacalcet, 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 47335-380 included in the NDC Directory?

    Yes, Cinacalcet with product code 47335-380 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on May 15, 2019 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 NDC billing unit for package 47335-380-83?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 47335-380-83?

    The 11-digit format is 47335038083. 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
    5-3-247335-380-835-4-247335-0380-83