NDC 0006-0461-02 Emend

Aprepitant

NDC Package Code 0006-0461-02

The NDC Code 0006-0461-02 is assigned to a package of 2 capsule in 1 dose pack of Emend, a human prescription drug labeled by Merck Sharp & Dohme Corp.. The product's dosage form is capsule and is administered via oral form.

Field Name	Field Value
NDC Code	0006-0461-02
Package Description	2 CAPSULE in 1 DOSE PACK
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	Aprepitant 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.
11-Digit NDC Billing Format	00006046102 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	Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s)	Oral - Administration to or by way of the mouth.
Active Ingredient(s)	APREPITANT 80 mg/1
Pharmacological Class(es)	Neurokinin 1 Antagonists - [MoA] (Mechanism of Action) Substance P/Neurokinin-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class) Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action) Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action) Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
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	NDA021549 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	03-26-2003 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	12-31-2020 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.

NDC Code Structure

0006 - Merck Sharp & Dohme Corp.
- 0006-0461 - Emend
  - 0006-0461-02 - 2 CAPSULE in 1 DOSE PACK

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 0006-0461-02 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
00006046102	J8501	Oral aprepitant	5 MG	1	2	16	32

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Pill Identification

aprepitant 80 MG Oral Capsule [Emend]
Image Labeler: Merck Sharp & Dohme Corp.

Physical Characteristics

What does emend look like?
Emend may look like a white capsule shaped capsule; approximately 18 millimeters in size. The medicine is imprinted with black printed code(s) 461 and 80 and mg.

Shape: CAPSULE
Size: 18 mm
Color: WHITE
Imprint: 461;80;mg
Imprint Color: BLACK
Imprint Type: PRINTED

Other Product Packages

The following packages are also available for Emend with product NDC 0006-0461.

NDC Package Code	Package Description
0006-0461-06	1 BLISTER PACK in 1 CARTON > 6 CAPSULE in 1 BLISTER PACK (0006-0461-01)
0006-0461-12	2 CAPSULE in 1 DOSE PACK

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