NDC Package Code 0006-3061-00
The NDC Code 0006-3061-00 is assigned to a package of 1 vial, single-dose in 1 carton > 5 ml in 1 vial, single-dose (0006-3061-01) of Emend, a human prescription drug labeled by Merck Sharp & Dohme Corp.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.
|Field Name||Field Value|
|Package Description||1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01)|
|Proprietary Name||Emend 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||Fosaprepitant Dimeglumine 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||Aprepitant is used with other medications to help prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). This medication is also used to prevent nausea and vomiting after surgery. Aprepitant works by blocking one of the body's natural substances (substance P/neurokinin 1) that causes vomiting. This medication will not treat nausea or vomiting that has already started. Ask your doctor what you should do if you already have nausea or vomiting.|
|11-Digit NDC Billing Format||00006306100 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||EA - Billing unit of "each" is used when the product is dispensed in discreet units.|
|Product Type||Human Prescription Drug 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||Merck Sharp & Dohme Corp.|
|Dosage Form||Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.|
|Sample Package||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
|Marketing Category||NDA - A product marketed under an approved New Drug 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||NDA022023 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||02-03-2017 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 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 0006-3061-00 HCPCS crosswalk information with package details and bill units information.
|NDC Billing Code||HCPCS Code||HCPCS Code Desc.||Dosage||Package Size||Package Quantity||Billable Units||Billable Units / Pkg|
|00006306100||J1453||Fosaprepitant injection||1 MG||1||1||150||150|
* Please review the disclaimer below.
Other Product Packages
The following packages are also available for Emend with product NDC 0006-3061.
|NDC Package Code||Package Description|
|0006-3061-02||1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-03)|
|0006-3061-04||1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01)|
* Please review the disclaimer below.