63304-958 NDC - CEPHALEXIN ()

Drug Information

Field Name	Field Value
Labeler Name:	Ranbaxy Pharmaceuticals Inc.
Product Type:
FDA Application Number:	ANDA065081
Marketing Category:	ANDA
Start Marketing Date:	10/29/2001

No.	Package Code	Package Description	Billing Unit
1	63304-958-01	100 mL in 1 BOTTLE (63304-958-01)	ML
2	63304-958-02	200 mL in 1 BOTTLE (63304-958-02)	ML

Field Name	Field Value	Definition
PRODUCT NDC	63304-958	The translation of the route code submitted by the firm, indicating route of administration.
PROPRIETARY NAME	CEPHALEXIN	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	10/29/2001	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.
MARKETING CATEGORY NAME	ANDA	Name of Company corresponding to the labeler code segment of the Product NDC.
APPLICATION NUMBER	ANDA065081	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	Ranbaxy Pharmaceuticals Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.