NDC 0004-0822 Tamiflu
Oseltamivir Phosphate Powder, For Suspension Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0004-0822?
    5. Tamiflu Uses
    6. Active Ingredients
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Patient Education

Product Information

NDC Product Code0004-0822
Proprietary Name 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.		Tamiflu
Non-Proprietary Name 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.		Oseltamivir Phosphate
Substance Name What is the Substance Name?
An 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.		Oseltamivir Phosphate
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormPowder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Genentech, Inc.
Labeler Code0004
SPL SET ID:ee3c9555-60f2-4f82-a760-11983c86e97b
FDA Application Number 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.		NDA021246
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-21-2011
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Characteristics

Color(s)YELLOW (C48330 - LIGHT YELLOW)
GRAY (C48324)
ShapeCAPSULE (C48336)
Size(s)14 MM
18 MM
Imprint(s)ROCHE;30;MG
ROCHE;45;MG
ROCHE;75;MG
Score1
Flavor(s)TUTTI FRUTTI (C73420)

Product Packages

NDC Code 0004-0822-05

Package Description: 1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS

Price per Unit: $2.43944 per ML

Product Details

What is NDC 0004-0822?

The NDC code 0004-0822 is assigned by the FDA to the product Tamiflu which is a human prescription drug product labeled by Genentech, Inc.. The generic name of Tamiflu is oseltamivir phosphate. The product's dosage form is powder, for suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 0004-0822-05 1 bottle, glass in 1 carton / 60 ml in 1 bottle, glass. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Tamiflu?

Oseltamivir is used to treat symptoms caused by the flu virus (influenza). It helps make the symptoms (such as stuffy nose, cough, sore throat, fever/chills, aches, tiredness) less severe and shortens the recovery time by 1-2 days. This medication may also be used to prevent the flu if you have been exposed to someone who already has the flu (such as a sick household member) or if there is a flu outbreak in the community. Talk to your doctor for more details. This medication works by stopping the flu virus from growing. It is not a substitute for the flu vaccine. (See also Notes section.)

What are Tamiflu Active Ingredients?

An 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.

Which are Tamiflu Inactive Ingredients 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 Tamiflu?

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:

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Patient Education

Oseltamivir


Oseltamivir is used to treat some types of influenza infection ('flu') in adults, children, and infants (older than 2 weeks of age) who have had symptoms of the flu for no longer than 2 days. This medication is also used to prevent some types of flu in adults and children (older than 1 year of age) when they have spent time with someone who has the flu or when there is a flu outbreak. Oseltamivir is in a class of medications called neuraminidase inhibitors. It works by stopping the spread of the flu virus in the body. Oseltamivir helps shorten the time that flu symptoms such as a stuffy or runny nose, sore throat, cough, muscle or joint aches, tiredness, headache, fever, and chills last. Oseltamivir will not prevent bacterial infections, which may occur as a complication of the flu.
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Product Label

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