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  5. NDC Package Code: 63629-8351-1 Pilocarpine Hydrochloride

NDC Package 63629-8351-1 Pilocarpine Hydrochloride

Tablet, Film Coated 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:
63629-8351-1
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
63629-8351
Proprietary Name:
Pilocarpine Hydrochloride
Non-Proprietary Name:
Pilocarpine Hydrochloride
Substance Name:
Pilocarpine Hydrochloride
Usage Information:
Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's syndrome.
11-Digit NDC Billing Format:
63629835101
NDC to RxNorm Crosswalk:
  • RxCUI: 1000913 - pilocarpine HCl 5 MG Oral Tablet
  • RxCUI: 1000913 - pilocarpine hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    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):
  • PILOCARPINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Cholinergic Agonists - [MoA] (Mechanism of Action)
  • Cholinergic Muscarinic Agonists - [MoA] (Mechanism of Action)
  • Cholinergic Receptor Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077220
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-14-2005
    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 63629-8351-1?

    The NDC Packaged Code 63629-8351-1 is assigned to a package of 30 tablet, film coated in 1 bottle of Pilocarpine Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 63629-8351 included in the NDC Directory?

    Yes, Pilocarpine Hydrochloride with product code 63629-8351 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on October 14, 2005 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 63629-8351-1?

    The 11-digit format is 63629835101. 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
    5-4-163629-8351-15-4-263629-8351-01