44206-300 NDC - RHOPHYLAC (HUMAN RHO(D) IMMUNE GLOBULIN)

Drug Information

Product NDC: 44206-300

Proprietary Name: Rhophylac

Non Proprietary Name: HUMAN RHO(D) IMMUNE GLOBULIN

Active Ingredient(s):
  • 1500 [iU]/2mL HUMAN RHO(D) IMMUNE GLOBULIN


Administration Route(s): INTRAMUSCULAR; INTRAVENOUS

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • Endogenous Antigen Neutralization [MoA];
  • Human Immunoglobulin G [EPC];
  • Immunoglobulins [CS];
  • Passively Acquired Immunity [PE]

Labeler Information

Labeler Name: CSL Behring AG
Product Type: PLASMA DERIVATIVE
FDA Application Number: BLA125070
Marketing Category: BLA
Start Marketing Date:1/6/2009

Package Information

No. Package Code Package Description Billing Unit
144206-300-011 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90)ML
244206-300-1010 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC44206-300The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEPLASMA DERIVATIVEIndicates 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.
PROPRIETARY NAMERhophylacThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEHUMAN RHO(D) IMMUNE GLOBULINThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULAR; INTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/6/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA125070This 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.
LABELER NAMECSL Behring AGName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHUMAN RHO(D) IMMUNE GLOBULINAn 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.
ACTIVE NUMERATOR STRENGTH1500 
ACTIVE INGRED UNIT[iU]/2mL 
PHARM CLASSESEndogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE] 

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This page was last updated on: 2/1/2023