Application 019953

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	Yes	Yes
002	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	Yes	Yes
003	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/100ML	Yes	Yes
004	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/100ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-9872	Heparin Sodium in Sodium Chloride	Heparin Sodium in Sodium Chloride	B. Braun Medical Inc.	NDA	Current