NDC 69448-014-63 Camcevi
Leuprolide Injection, Emulsion Subcutaneous

Package Information

What is NDC 69448-014-63?

The NDC Code 69448-014-63 is assigned to a package of 1 syringe in 1 carton / .37 g in 1 syringe of Camcevi, a human prescription drug labeled by Accord Biopharma, Inc.. The product's dosage form is injection, emulsion and is administered via subcutaneous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. The following table has all the important details about this NDC code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

Field Name Field Value
NDC Code 69448-014-63
Package Description 1 SYRINGE in 1 CARTON / .37 g in 1 SYRINGE
Product Code 69448-014
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Camcevi
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Leuprolide
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
69448001463
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Estimated Billable Units per Package 1 EA
NDC to RxNorm Crosswalk
  • RxCUI: 2595044 - leuprolide 42 MG Prefilled Syringe
  • RxCUI: 2595044 - leuprolide 42 MG (as leuprolide mesylate 48 MG) Prefilled Syringe
  • RxCUI: 2595049 - CAMCEVI 42 MG Prefilled Syringe
  • RxCUI: 2595049 - leuprolide 42 MG Prefilled Syringe [Camcevi]
  • RxCUI: 2595049 - Camcevi 42 MG Prefilled Syringe
  • Product Type What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
    Human Prescription Drug
    Labeler Name Accord Biopharma, Inc.
    Dosage Form Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
    Administration Route(s)
    • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    Active Ingredient(s)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
    NDA - A product marketed under an approved New Drug Application.
    FDA Application Number What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
    NDA211488
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    04-05-2022
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    12-31-2023
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    N
    NDC 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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 69448-014-63 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    69448001463J1952Leuprolide inj, camcevi, 1mg1 MG114242

    * Please review the disclaimer below.