53808-0967 NDC - TOPIRAMATE ()

Drug Information

Field Name	Field Value
Labeler Name:	State of Florida DOH Central Pharmacy
Product Type:
FDA Application Number:	ANDA090278
Marketing Category:	ANDA
Start Marketing Date:	7/1/2009

No.	Package Code	Package Description	Billing Unit
1	53808-0967-1	30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0967-1)

Field Name	Field Value	Definition
PRODUCT NDC	53808-0967	The 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.
PROPRIETARY NAME	TOPIRAMATE	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.
START MARKETING DATE	7/1/2009	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAME	ANDA	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
APPLICATION NUMBER	ANDA090278	The translation of the dosage form Code submitted by the firm.
LABELER NAME	State of Florida DOH Central Pharmacy	The translation of the route code submitted by the firm, indicating route of administration.