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  5. NDC Package Code: 70771-1626-8 Fulvestrant

NDC Package 70771-1626-8 Fulvestrant

Injection, Solution 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:
70771-1626-8
Package Description:
2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS (70771-1626-2)
Product Code:
70771-1626
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:
70771162608
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:
    Zydus Lifesciences Limited
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • FULVESTRANT 50 mg/mL
    • 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:
    ANDA215234
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-14-2021
    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 70771-1626-8?

    The NDC Packaged Code 70771-1626-8 is assigned to a package of 2 syringe, glass in 1 carton / 5 ml in 1 syringe, glass (70771-1626-2) of Fulvestrant, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is injection, solution and is administered via intramuscular form.

    Is NDC 70771-1626 included in the NDC Directory?

    Yes, Fulvestrant with product code 70771-1626 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on December 14, 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 11-digit format for NDC 70771-1626-8?

    The 11-digit format is 70771162608. 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
    5-4-170771-1626-85-4-270771-1626-08