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  5. NDC Package Code: 63629-9499-1 Paroxetine

NDC Package 63629-9499-1 Paroxetine

Paroxetine Hydrochloride Hemihydrate Tablet, Film Coated, 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:
63629-9499-1
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
63629-9499
Proprietary Name:
Paroxetine
Non-Proprietary Name:
Paroxetine Hydrochloride Hemihydrate
Substance Name:
Paroxetine Hydrochloride Hemihydrate
Usage Information:
Paroxetine Extended-Release Tablets, USP are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
11-Digit NDC Billing Format:
63629949901
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: 1738805 - PARoxetine HCl 25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1738805 - 24 HR paroxetine hydrochloride 25 MG Extended Release Oral Tablet
  • RxCUI: 1738805 - paroxetine hydrochloride 25 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1
    • Pharmacologic Class(es):
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209293
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-14-2018
    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 63629-9499-1?

    The NDC Packaged Code 63629-9499-1 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle of Paroxetine, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet, film coated, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 63629-9499 included in the NDC Directory?

    Yes, Paroxetine with product code 63629-9499 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on September 14, 2018 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 63629-9499-1?

    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 63629-9499-1?

    The 11-digit format is 63629949901. 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 5-4-1 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
    5-4-163629-9499-15-4-263629-9499-01