Application 020161

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	745MG/100ML	Yes	No
002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	1.49GM/100ML	Yes	No
003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2.24GM/100ML	Yes	No
004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2.98GM/100ML	Yes	Yes
005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	14.9MG/ML	Yes	No
006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	29.8MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30
N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30
N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11
N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11
N020161-005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	14.9MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30
N020161-006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	29.8MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N020161-001	AP
N020161-002	AP
N020161-004	AP
N020161-005	AP
N020161-006	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 7 · 246 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
2026-02-19 14:30 UTC	2026-02	N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	14.9MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	29.8MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	14.9MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	29.8MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	14.9MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	29.8MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	14.9MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	29.8MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	14.9MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	29.8MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-005	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	14.9MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-006	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	29.8MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-001	POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	745MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-002	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	1.49GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-003	POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	2.24GM/100ML	INJECTABLE / INJECTION		RLD	1998-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-004	POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	2.98GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-08-11	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020161-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020161-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020161-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020161-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020161-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020161-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020161-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020161-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-005	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020161-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020161-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020161-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020161-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020161-005	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020161-006	AP	1	`5bbf6a4d5a75…`

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	POTASSIUM CHLORIDE	ICU Medical Inc.	eb56a807-ea94-4edb-9811-a04b19568468	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020161 application number: NDA020161 ndc (product): 0990-7074 ndc (product): 0990-7075 ndc (product): 0990-7077

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7074	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7074	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7074	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7075	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7075	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7075	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7076	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7076	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7077	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7077	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7077	Potassium Chloride	POTASSIUM CHLORIDE	Hospira, Inc.	NDA	Current
0990-7074	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7074	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7074	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7074	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7075	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7075	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7075	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7075	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7075	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7077	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7077	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7077	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7077	Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	NDA	Current