NDC 13533-618-02 Hyperrab S/d
Rabies Immune Globulin (human) Injection Intramuscular

Package Information

What is NDC 13533-618-02?

The NDC Packaged Code 13533-618-02 is assigned to a package of 1 vial, glass in 1 carton / 2 ml in 1 vial, glass (13533-618-20) of Hyperrab S/d, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection and is administered via intramuscular 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 13533-618-02
Package Description 1 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS (13533-618-20)
Product Code 13533-618
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.		 Hyperrab S/d
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.		 Rabies Immune Globulin (human)
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		 Human Rabies Virus Immune Globulin
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.		 Rabies vaccine and HyperRAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. HyperRAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP). [19]Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated:
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.		 13533061802
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk
  • RxCUI: 1652827 - rabies immune globulin, human 150 UNT/ML in 2 ML Injection
  • RxCUI: 1652827 - 2 ML rabies immune globulin, human 150 UNT/ML Injection
  • RxCUI: 1652827 - rabies immune globulin, human 150 UNT/ML per 2 ML Injection
  • RxCUI: 1652830 - HyperRAB 150 UNT/ML in 2 ML Injection
  • RxCUI: 1652830 - 2 ML rabies immune globulin, human 150 UNT/ML Injection [HyperRAB]
    • 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.    		 Plasma Derivative
    Labeler Name Grifols Usa, Llc
    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)
    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.    		 BLA - A product marketed under an approved Biologic License 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.    		 BLA101144
    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.    		 08-14-1996
    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.

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    Other Product Packages

    The following packages are also available for Hyperrab with product NDC 13533-618.

    NDC Package CodePackage Description
    13533-618-101 VIAL in 1 CARTON / 10 mL in 1 VIAL (13533-618-11)

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