Application 019685

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	Yes	No
002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	Yes	No
003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	Yes	No
004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	Yes	No
005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	Yes	No
006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	Yes	No
007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	Yes	No
008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019685-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17
N019685-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-10-17
N019685-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17
N019685-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17
N019685-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17
N019685-006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17
N019685-007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17
N019685-008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019685-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019685-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019685-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019685-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019685-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019685-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019685-006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019685-007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019685-008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019685-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019685-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019685-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019685-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019685-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019685-006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019685-007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019685-008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019685-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019685-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019685-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019685-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019685-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019685-006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019685-007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019685-008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019685-008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019685-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019685-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019685-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019685-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019685-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019685-006	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019685-007	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019685-008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		RLD	1988-10-17	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N019685-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019685-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019685-002	AP	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	237b39fa-916e-4a54-99c8-4ae9ad54f056	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019685 application number: NDA019685 ndc (product): 0990-7111

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7111	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7111	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7113	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0990-7111	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7111	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7111	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7111	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current
0990-7111	Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE	ICU Medical Inc.	NDA	Current