NDC 13533-800-12 Gamunex-c

Immune Globulin (human)

  1. Labeler Index
  2. Grifols Usa, Llc
  3. 13533-800
  4. NDC Code: 13533-800-12 Gamunex-c

NDC Package Code 13533-800-12

The NDC Code 13533-800-12 is assigned to a package of 1 vial, glass in 1 carton > 10 ml in 1 vial, glass (13533-800-13) of Gamunex-c, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection and is administered via intravenous; subcutaneous form.

Field Name Field Value
NDC Code 13533-800-12
Package Description 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS (13533-800-13)
Proprietary Name Gamunex-c What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Immune Globulin (human) 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.
Drug Uses This medication is used in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This medication is made from human blood that has a high level of antibodies which help fight infections. This product is also used to increase the number of certain blood cells (platelets) in people with a certain blood disorder (idiopathic thrombocytopenic purpura-ITP). Platelets are needed to stop bleeding and to form normal blood clots. In addition, this medication is used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps to improve these symptoms and prevents relapse.
11-Digit NDC Billing Format 13533080012 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Plasma Derivative 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.
Labeler Name Grifols Usa, Llc
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s)
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
  • HUMAN IMMUNOGLOBULIN G 10 g/100mL
Pharmacological Class(es)
  • Human Immunoglobulin G - [EPC] (Established Pharmacologic Class)
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
  • Antigen Neutralization - [MoA] (Mechanism of Action)
  • Immunoglobulins - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category BLA - A product marketed under an approved Biologic License Application. 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.
FDA Application Number BLA125046 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.
Start Marketing Date 10-13-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2021 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.
Exclude Flag N 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. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 13533 - Grifols Usa, Llc
    • 13533-800 - Gamunex-c
      • 13533-800-12 - 1 VIAL, GLASS in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 13533-800-12 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
13533080012J1561Gamunex-c/gammaked500 MG10122

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Other Product Packages

The following packages are also available for Gamunex-c with product NDC 13533-800.

NDC Package CodePackage Description
13533-800-151 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS (13533-800-16)
13533-800-201 VIAL, GLASS in 1 CARTON > 50 mL in 1 VIAL, GLASS (13533-800-21)
13533-800-241 VIAL, GLASS in 1 CARTON > 200 mL in 1 VIAL, GLASS (13533-800-25)
13533-800-401 VIAL, GLASS in 1 CARTON > 400 mL in 1 VIAL, GLASS (13533-800-41)
13533-800-711 VIAL, GLASS in 1 CARTON > 100 mL in 1 VIAL, GLASS (13533-800-72)

* Please review the disclaimer below.