Glucose / Potassium Chloride Injectable Solution

Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Baxter Healthcare Corporation (2015-03-07)
Oldest Current Product: 1979-02-01
License(s): NDA

RxNORM: INJECTABLE SOLUTION\GLUCOSE:POTASSIUM CHLORIDE
FDAOB: INJECTION\INJECTION\DEXTROSE: POTASSIUM CHLORIDE\rdfq
SPL Active: INTRAVENOUS\INJECTION, SOLUTION\DEXTROSE MONOHYDRATE: POTASSIUM CHLORIDE
INTRAVENOUS\SOLUTION\DEXTROSE, UNSPECIFIED FORM: POTASSIUM CHLORIDE
SPL Moiety: INTRAVENOUS\INJECTION, SOLUTION\ANHYDROUS DEXTROSE: CHLORIDE ION
INTRAVENOUS\SOLUTION\DEXTROSE, UNSPECIFIED FORM: POTASSIUM CATION

product(s) by strength(s)

glucose 50 mg/ml / potassium chloride 0.02 meq/ml injectable solution

original product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	002647625	NDA	B. Braun Medical Inc.	1989-09-29	DEXTROSE, UNSPECIFIED FORM, POTASSIUM CHLORIDE	INTRAVENOUS	SOLUTION	NDA019699	e5bbb3e1-ab50-4ec7-a2b4-ce4091712e23
2	003380683	NDA	Baxter Healthcare Corporation	1979-02-01	DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE	INTRAVENOUS	INJECTION, SOLUTION	NDA017634	45de5402-5e61-4bbd-8bbc-5e3392c9920e

glucose 50 mg/ml / potassium chloride 0.03 meq/ml injectable solution

original product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	004097996	NDA	Hospira, Inc.	1980-05-29	DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE	INTRAVENOUS	INJECTION, SOLUTION	NDA018371	6888a502-6fe6-4e4d-7c9f-be6d37700d8a

glucose 50 mg/ml / potassium chloride 0.04 meq/ml injectable solution

original product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	004097906	NDA	Hospira, Inc.	1980-05-29	DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE	INTRAVENOUS	INJECTION, SOLUTION	NDA018371	6888a502-6fe6-4e4d-7c9f-be6d37700d8a

application(s)

#	id	title	applicant	approved	approved drug
1	NDA017634	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	BAXTER HEALTHCARE CORP		NDA017634_001, NDA017634_002, NDA017634_003, NDA017634_004
2	NDA018371	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	HOSPIRA INC		NDA018371_001, NDA018371_002, NDA018371_003
3	NDA018744	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER	B BRAUN MEDICAL INC	1982-11-09	NDA018744_001, NDA018744_002, NDA018744_003, NDA018744_004
4	NDA019699	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER	B BRAUN MEDICAL INC	1989-09-29	NDA019699_001, NDA019699_002, NDA019699_003, NDA019699_004, NDA019699_005, NDA019699_006

application drug(s)

#	id	category/deprecated	ingredient strength(s)	dose form	rld	TE	approved	application
1	NDA017634_001	RX	DEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (150MG/100ML)	INJECTION	False	AP		DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
2	NDA017634_002	RX	DEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (300MG/100ML)	INJECTION	False	AP		DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
3	NDA017634_003	RX	DEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (224MG/100ML)	INJECTION	False	AP		DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
4	NDA017634_004	RX	POTASSIUM CHLORIDE (75MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False	AP		DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
5	NDA018371_001	RX	POTASSIUM CHLORIDE (149MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False			POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
6	NDA018371_002	RX	POTASSIUM CHLORIDE (298MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False			POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
7	NDA018371_003	RX	POTASSIUM CHLORIDE (224MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False	AP		POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
8	NDA018744_001	RX	POTASSIUM CHLORIDE (75MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False	AP	1982-11-09	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
9	NDA018744_002	RX	DEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (150MG/100ML)	INJECTION	False	AP	1982-11-09	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
10	NDA018744_003	discontinued	DEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (220MG/100ML)	INJECTION	False		1982-11-09	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
11	NDA018744_004	RX	POTASSIUM CHLORIDE (300MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False	AP	1982-11-09	POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
12	NDA019699_001	discontinued	POTASSIUM CHLORIDE (37MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False		1989-09-29	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
13	NDA019699_002	discontinued	POTASSIUM CHLORIDE (75MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False		1989-09-29	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
14	NDA019699_003	discontinued	DEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (110MG/100ML)	INJECTION	False		1989-09-29	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
15	NDA019699_004	RX	POTASSIUM CHLORIDE (150MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False	AP	1989-09-29	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
16	NDA019699_005	discontinued	DEXTROSE (5GM/100ML), POTASSIUM CHLORIDE (220MG/100ML)	INJECTION	False		1989-09-29	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
17	NDA019699_006	RX	POTASSIUM CHLORIDE (300MG/100ML), DEXTROSE (5GM/100ML)	INJECTION	False	AP	1989-09-29	POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	45de5402-5e61-4bbd-8bbc-5e3392c9920e (view SPL)	Potassium Chloride in 5% Dextrose Injection, USP in Plastic Container VIAFLEX Plus Container	prescription	Human Prescription	Baxter Healthcare Corporation	ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE	2015-03-07	7	003380683
2	6888a502-6fe6-4e4d-7c9f-be6d37700d8a (view SPL)	POTASSIUM CHLORIDEin Dextrose Injection, USP	prescription	Human Prescription	Hospira, Inc.		2014-03-13	12	004097906, 004097996, 004097905
3	e5bbb3e1-ab50-4ec7-a2b4-ce4091712e23 (view SPL)	Potassium Chloride in 5% Dextrose Injections USP	prescription	Human Prescription	B. Braun Medical Inc.		2011-07-11	8	002647625, 002647628

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII