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  5. NDC Package Code: 45802-491-84 Cyanocobalamin

NDC Package 45802-491-84 Cyanocobalamin

Spray Nasal - 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:
45802-491-84
Package Description:
4 BOTTLE, UNIT-DOSE in 1 CARTON / 1 SPRAY in 1 BOTTLE, UNIT-DOSE
Product Code:
45802-491
Proprietary Name:
Cyanocobalamin
Non-Proprietary Name:
Cyanocobalamin
Substance Name:
Cyanocobalamin
Usage Information:
Cyanocobalamin Nasal Spray is indicated for:•Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement •Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia •Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normalLimitations of Use•Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test). •In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long-term use of Cyanocobalamin Nasal Spray following adequate correction of vitamin B12 deficiency and underlying disease has not been established. •The effectiveness of Cyanocobalamin Nasal Spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with Cyanocobalamin Nasal Spray should be deferred until symptoms have subsided.
11-Digit NDC Billing Format:
45802049184
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
4 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 861113 - cyanocobalamin 500 MCG/ACTUAT Nasal Spray
  • RxCUI: 861113 - vitamin B12 0.5 MG/ACTUAT Nasal Spray
  • RxCUI: 861113 - vitamin B 12 500 MCG/ACTUAT Nasal Spray
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • CYANOCOBALAMIN 500 ug/1
    • Pharmacologic Class(es):
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA212458
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-28-2023
    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 45802-491-84?

    The NDC Packaged Code 45802-491-84 is assigned to a package of 4 bottle, unit-dose in 1 carton / 1 spray in 1 bottle, unit-dose of Cyanocobalamin, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is spray and is administered via nasal form.

    Is NDC 45802-491 included in the NDC Directory?

    Yes, Cyanocobalamin with product code 45802-491 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on December 28, 2023 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 NDC billing unit for package 45802-491-84?

    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 4.

    What is the 11-digit format for NDC 45802-491-84?

    The 11-digit format is 45802049184. 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
    5-3-245802-491-845-4-245802-0491-84