Application 078446

Type: ANDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	149MG/100ML;450MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP		2008-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078446-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078446-001	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2008-09-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078446-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078446-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078446-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078446-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078446-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078446-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078446-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078446-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078446-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078446-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078446-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078446-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078446-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078446-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078446-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078446-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078446-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078446-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078446-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078446-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078446-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078446-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078446-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078446-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078446-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078446-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078446-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078446-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078446-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078446-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078446-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078446-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078446-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078446-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078446-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078446-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078446-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078446-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078446-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078446-001	AP	1	`e64feba35796…`

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 Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	243fe8fc-996a-4855-8daf-069628e547c4	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078446 application number: ANDA078446 ndc (product): 0990-9257

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-9257	Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE and POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-9257	Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE and POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-9257	Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE and POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0990-9257	Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE and POTASSIUM CHLORIDE	ICU Medical Inc.	ANDA	Current
0990-9257	Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE and POTASSIUM CHLORIDE	ICU Medical Inc.	ANDA	Current
0990-9257	Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE and POTASSIUM CHLORIDE	ICU Medical Inc.	ANDA	Current
0990-9257	Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE and POTASSIUM CHLORIDE	ICU Medical Inc.	ANDA	Current