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  5. NDC Package Code: 43353-984-05 Galantamine Hydrobromide

NDC Package 43353-984-05 Galantamine Hydrobromide

Capsule, Extended Release 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:
43353-984-05
Package Description:
4200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
43353-984
Proprietary Name:
Galantamine Hydrobromide
Non-Proprietary Name:
Galantamine Hydrobromide
Substance Name:
Galantamine Hydrobromide
Usage Information:
Galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. It does not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by restoring the balance of certain natural substances (neurotransmitters) in the brain.
11-Digit NDC Billing Format:
43353098405
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
4200 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 860695 - galantamine HBr 16 MG 24HR Extended Release Oral Capsule
  • RxCUI: 860695 - 24 HR galantamine hydrobromide 16 MG Extended Release Oral Capsule
  • RxCUI: 860695 - galantamine hydrobromide 16 MG 24 HR Extended Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aphena Pharma Solutions - Tennessee, Llc
    Dosage Form:
    Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GALANTAMINE HYDROBROMIDE 16 mg/1
    • Pharmacologic Class(es):
  • Cholinesterase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cholinesterase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA079028
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-15-2009
    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 43353-984-05?

    The NDC Packaged Code 43353-984-05 is assigned to a package of 4200 capsule, extended release in 1 bottle of Galantamine Hydrobromide, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is capsule, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 4200 billable units per package.

    Is NDC 43353-984 included in the NDC Directory?

    Yes, Galantamine Hydrobromide with product code 43353-984 is active and included in the NDC Directory. The product was first marketed by Aphena Pharma Solutions - Tennessee, Llc on December 15, 2009 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 43353-984-05?

    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 4200.

    What is the 11-digit format for NDC 43353-984-05?

    The 11-digit format is 43353098405. 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
    5-3-243353-984-055-4-243353-0984-05