Rhogam Ultra-filtered Plus Injection, Solution
NDC 0562-7805
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Rhogam Ultra-filtered Plus (human rho(d) immune globulin) is a BLA-approved product labeled by Kedrion Biopharma Inc. This medication is typically used as a endogenous antigen neutralization [moa]. It is supplied as a injection, solution for intramuscular administration. This product entry covers the primary NDC 0562-7805 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0562-7805
Proprietary Name:
Rhogam Ultra-filtered Plus
Non-Proprietary Name: [1]
Human Rho(d) Immune Globulin
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:
Injection, Solution
- A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
Intramuscular - Administration within a muscle.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0562
Product Label ID:
HCPCS Code:
J2790
- INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, FULL DOSE, 300 MICROGRAMS (1500 I.U.)
FDA Application Number: [6]
BLA103777
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
03-09-2007
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0562-7805?
The NDC code 0562-7805 is assigned by the FDA to the product Rhogam Ultra-filtered Plus. It is commonly known by its generic name, human rho(d) immune globulin. This pharmaceutical product is labeled by Kedrion Biopharma Inc and is currently categorized as listed product. The medication is a injection, solution administered via intramuscular route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 0562-7805-01, 0562-7805-05, 0562-7805-25. 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?
IndicationDoseNotesPregnancy and other obstetrical conditions.Postpartum (if the newborn is Rh-positive)RhoGAM(300 μg)(1500 IU)Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. This may be determined by use of qualitative or quantitative tests for fetal-maternal hemorrhage.Administer within 72 hours of delivery.Antepartum:Prophylaxis at 26 to 28 weeks gestation Administer within 72 hours of suspected or proven exposure to Rh-positive red blood cells resulting from:Amniocentesis, chorionic villus sampling (CVS) and percutaneous umbilical blood sampling (PUBS)Abdominal trauma or obstetrical manipulationEctopic pregnancyThreatened pregnancy loss after 12 weeks gestation with continuation of pregnancyPregnancy termination (spontaneous or induced) beyond 12 weeks gestationIf antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive.If RhoGAM is administered early in pregnancy (before 26 to 28 weeks), there is an obligation to maintain a level of passively acquired anti-D by administration of RhoGAM at 12-week intervals.Actual or threatened termination of pregnancy (spontaneous or induced) up to and including 12 weeks gestation Administer within 72 hoursMICRhoGAM(50 μg)(250 IU)RhoGAM may be administered if MICRhoGAM is not available.Transfusion of Rh-incompatible blood or blood productsAdminister within 72 hours of suspected or proven exposure to Rh-positive red blood cells.< 2.5 mL Rh-positive red blood cellsMICRhoGAM(50 μg)(250 IU)RhoGAM may be administered if MICRhoGAM is not available.2.5 - 15.0 mL Rh-positive red blood cellsRhoGAM(300 μg)(1500 IU)> 15.0 mL Rh-positive red blood cellsRhoGAM(300 μg)(1500 IU)(multiple syringes)Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. Administer 20 μg of RhoGAM per mL of Rh-positive red blood cell exposure. Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within three days of exposure.
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:
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- GLYCINE (UNII: TE7660XO1C)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
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: 731380 - MICRhoGAM 250 UNT (50 MCG) Prefilled Syringe
- RxCUI: 731380 - Rho(D) immune globulin, human 250 UNT Prefilled Syringe [MICRhoGAM]
- RxCUI: 731380 - MICRhoGAM 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".
