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NDC 13533-661 Hyperrho S/d Mini-dose

Rho(d) Immune Globulin (human) Solution Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13533-661?
  5. Hyperrho S/d Mini-dose Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
13533-661
Proprietary Name:
Hyperrho S/d Mini-dose
Non-Proprietary Name: [1]
Rho(d) Immune Globulin (human)
Substance Name: [2]
Human Rho(d) Immune Globulin
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Grifols Usa, Llc
    Labeler Code:
    13533
    Product Label ID:
    b2ff5610-722c-523e-961d-668d60f82d9e
    FDA Application Number: [6]
    BLA101141
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    08-14-1996
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - YELLOW (CLEAR LIQUID, COLORLESS TO PALE YELLOW OR PINK))

    Code Structure Chart

    Product Details

    What is NDC 13533-661?

    The NDC code 13533-661 is assigned by the FDA to the product Hyperrho S/d Mini-dose which is a plasma derivative product labeled by Grifols Usa, Llc. The generic name of Hyperrho S/d Mini-dose is rho(d) immune globulin (human). The product's dosage form is solution and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 13533-661-06 10 syringe in 1 carton / 1 solution in 1 syringe (13533-661-60). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Hyperrho S/d Mini-dose?

    HyperRHO S/D Mini-Dose is recommended to prevent the isoimmunization of Rho(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks’ gestation provided the following criteria are met:The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) antigen. The father is not known to be Rho(D) negative.Gestation is not more than 12 weeks at termination.Note: Rho(D) Immune Globulin (Human) prophylaxis is not indicated if the fetus or father can be determined to be Rh negative. If the Rh status of the fetus is unknown, the fetus must be assumed to be Rho(D) positive, and HyperRHO S/D Mini-Dose should be administered to the mother.FOR ABORTIONS OR MISCARRIAGES OCCURRING AFTER 12 WEEKS’ GESTATION, A STANDARD DOSE OF Rho(D) IMMUNE GLOBULIN (HUMAN) IS INDICATED.HyperRHO S/D Mini-Dose should be administered within 3 hours or as soon as possible after spontaneous passage or surgical removal of the products of conception. However, if HyperRHO S/D Mini-Dose is not given within this time period, consideration should still be given to its administration since clinical studies in male volunteers have demonstrated the effectiveness of Rho(D) Immune Globulin (Human) in preventing isoimmunization as long as 72 hours after infusion of Rho(D) positive red cells. [9]

    What are Hyperrho S/d Mini-dose Active Ingredients?

    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.

    Which are Hyperrho S/d Mini-dose UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • HUMAN RHO(D) IMMUNE GLOBULIN (UNII: 48W7181FLP)
    • HUMAN RHO(D) IMMUNE GLOBULIN (UNII: 48W7181FLP) (Active Moiety)

    Which are Hyperrho S/d Mini-dose Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Hyperrho S/d Mini-dose?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1790353 - rho(D) immune globulin, human 250 UNT (50 MCG) Prefilled Syringe
    • RxCUI: 1790353 - Rho(D) immune globulin, human 250 UNT Prefilled Syringe
    • RxCUI: 898572 - HyperRHO Mini-Dose 250 UNT (50 MCG) Prefilled Syringe
    • RxCUI: 898572 - Rho(D) immune globulin, human 250 UNT Prefilled Syringe [HyperRHO]
    • RxCUI: 898572 - HyperRHO 250 UNT Prefilled Syringe

    Which are the Pharmacologic Classes for Hyperrho S/d Mini-dose?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".