54868-6416 NDC - KETOROLAC TROMETHAMINE ()

Drug Information

No.	Package Code	Package Description	Billing Unit
1	54868-6416-0	1 BOTTLE, DROPPER in 1 CARTON (54868-6416-0) / 5 mL in 1 BOTTLE, DROPPER

Field Name	Field Value	Definition
PRODUCT NDC	54868-6416	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.
PROPRIETARY NAME	KETOROLAC TROMETHAMINE	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
START MARKETING DATE	3/28/2014	The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAME	NDA AUTHORIZED GENERIC	This is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBER	NDA021528	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.
LABELER NAME	Physicians Total Care, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.