Hyperrho Solution
NDC 13533-661
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Hyperrho (rho(d) immune globulin (human)) is a BLA-approved product labeled by Grifols Usa, Llc. This medication is typically used as a endogenous antigen neutralization [moa]. It is supplied as a yellow solution for intramuscular administration. This product entry covers the primary NDC 13533-661 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
13533-661
Proprietary Name:
Hyperrho 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
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
13533
Product Label ID:
HCPCS Code:
J2788
- INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, MINIDOSE, 50 MICROGRAMS (250 I.U.)
FDA Application Number: [6]
BLA101141
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
08-14-1996
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
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 Mini-dose. It is commonly known by its generic name, rho(d) immune globulin (human). This pharmaceutical product is labeled by Grifols Usa, Llc and is currently categorized as listed product. The medication is a solution administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 13533-661-06. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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 Active Ingredients of this product?
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 the associated 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 the Inactive Ingredients associated 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:
- GLYCINE (UNII: TE7660XO1C)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for this product?
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 of this product?
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.
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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
