NDC 62559-860-15 Purified Cortrophin Gel
Repository Corticotropin Injection Intramuscular; Subcutaneous

Package Information

What is NDC 62559-860-15?

The NDC Code 62559-860-15 is assigned to a package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Purified Cortrophin Gel, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. The product's dosage form is injection and is administered via intramuscular; subcutaneous form. 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 Package Code 62559-860-15
Package Description 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code 62559-860
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.
Purified Cortrophin Gel
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.
Repository Corticotropin
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.
Purified Cortrophin Gel is indicated in the following disorders:1. Rheumatic disorders:  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).Ankylosing spondylitis.Acute gouty arthritis. 2. Collagen diseases:  During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). 3. Dermatologic diseases:  Severe erythema multiforme (Stevens-Johnson syndrome).Severe psoriasis.4. Allergic states:  Atopic dermatitisSerum sickness. 5. Ophthalmic diseases:  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitis.Keratitis. Iritis and iridocyclitis.Diffuse posterior uveitis and choroiditis.Optic neuritis.Chorioretinitis. Anterior segment inflammation. 6. Respiratory diseases:  Symptomatic sarcoidosis. 7. Edematous states: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. 8. Nervous system: Acute exacerbations of multiple sclerosis.
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.
62559086015
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk
  • RxCUI: 2584475 - CORTROPHIN 80 UNT/ML Injectable Solution
  • RxCUI: 2584475 - corticotropin 80 UNT/ML Injectable Solution [Cortrophin]
  • RxCUI: 2584475 - Cortrophin 400 UNT per 5 ML Injectable Solution
  • RxCUI: 2584475 - Cortrophin 80 UNT/ML Injectable Solution
  • RxCUI: 309541 - corticotropin 80 UNT/ML Injectable Solution
  • 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 Ani Pharmaceuticals, Inc.
    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.
    • 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.
    NDA008975
    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.
    10-29-2021
    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 62559-860-15 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    62559086015J0800Corticotropin injection40 UNITS511010

    * Please review the disclaimer below.