Micrhogam Ultra-filtered Plus
NDC 0562-7806

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0562-7806?
  4. Micrhogam Ultra-filtered Plus Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Micrhogam Ultra-filtered Plus is a BLA-approved product labeled by Kedrion Biopharma Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 0562-7806 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0562-7806
Proprietary Name:
Micrhogam Ultra-filtered Plus
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Kedrion Biopharma Inc
Labeler Code:
0562
Product Label ID:
d87e4d0b-2442-4135-b3f9-5c4f74845b87
HCPCS Code:
J2788 - INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, MINIDOSE, 50 MICROGRAMS (250 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
End Marketing Date: [10]
01-28-2024
Listing Expiration Date: [11]
01-28-2024
Exclude Flag: [12]
D

Code Structure Chart

Product Details

What is NDC 0562-7806?

The NDC code 0562-7806 is assigned by the FDA to the product Micrhogam Ultra-filtered Plus. This pharmaceutical product is labeled by Kedrion Biopharma Inc and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 0562-7806-01, 0562-7806-05, 0562-7806-25. 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.

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:

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

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Product & Regulatory Definitions
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".