1. Home
  2. Labeler Index
  3. Sandoz Inc
  4. 61314-637
  5. NDC Package Code: 61314-637-10 Prednisolone Acetate

NDC Package 61314-637-10 Prednisolone Acetate

Suspension/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
61314-637-10
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 10 mL in 1 BOTTLE, PLASTIC
Product Code:
61314-637
Proprietary Name:
Prednisolone Acetate
Non-Proprietary Name:
Prednisolone Acetate
Substance Name:
Prednisolone Acetate
Usage Information:
This medication is used to treat certain eye conditions due to inflammation or injury. Prednisolone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.
11-Digit NDC Billing Format:
61314063710
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1376336 - prednisoLONE acetate 1 % Ophthalmic Suspension
  • RxCUI: 1376336 - prednisolone acetate 10 MG/ML Ophthalmic Suspension
  • RxCUI: 1376336 - prednisolone acetate 1 % Ophthalmic Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • PREDNISOLONE ACETATE 10 mg/mL
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA017469
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    12-15-1994
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61314-637-051 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
    61314-637-151 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61314-637-10?

    The NDC Packaged Code 61314-637-10 is assigned to a package of 1 bottle, plastic in 1 carton / 10 ml in 1 bottle, plastic of Prednisolone Acetate, a human prescription drug labeled by Sandoz Inc. The product's dosage form is suspension/ drops and is administered via ophthalmic form.

    Is NDC 61314-637 included in the NDC Directory?

    Yes, Prednisolone Acetate with product code 61314-637 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on December 15, 1994 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 61314-637-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 61314-637-10?

    The 11-digit format is 61314063710. 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
    5-3-261314-637-105-4-261314-0637-10