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  5. NDC Package Code: 68001-522-85 Fulvestrant

NDC Package 68001-522-85 Fulvestrant

Injection Intramuscular - 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:
68001-522-85
Package Description:
2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS (68001-522-86)
Product Code:
68001-522
Proprietary Name:
Fulvestrant
Non-Proprietary Name:
Fulvestrant
Substance Name:
Fulvestrant
Usage Information:
Fulvestrant is used to treat certain types of breast cancer. Breast cancer cells need the hormone estrogen in order to grow. Fulvestrant works by blocking the effect of estrogen, slowing tumor cell growth.
11-Digit NDC Billing Format:
68001052285
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 727762 - fulvestrant 250 MG in 5 ML Prefilled Syringe
  • RxCUI: 727762 - 5 ML fulvestrant 50 MG/ML Prefilled Syringe
  • RxCUI: 727762 - fulvestrant 250 MG per 5 ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bluepoint Laboratories
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • FULVESTRANT 250 mg/5mL
    • Pharmacologic Class(es):
  • Estrogen Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Estrogen Receptor Antagonists - [MoA] (Mechanism of Action)
  • Selective Estrogen Receptor Modulators - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211689
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-29-2021
    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 68001-522-85?

    The NDC Packaged Code 68001-522-85 is assigned to a package of 2 syringe, glass in 1 carton / 5 ml in 1 syringe, glass (68001-522-86) of Fulvestrant, a human prescription drug labeled by Bluepoint Laboratories. The product's dosage form is injection and is administered via intramuscular form.

    Is NDC 68001-522 included in the NDC Directory?

    Yes, Fulvestrant with product code 68001-522 is active and included in the NDC Directory. The product was first marketed by Bluepoint Laboratories on October 29, 2021 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 68001-522-85?

    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 68001-522-85?

    The 11-digit format is 68001052285. 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
    5-3-268001-522-855-4-268001-0522-85