Application 088901

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2MEQ/ML	No	No

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

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
A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP		1985-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088901-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088901-001	POTASSIUM CHLORIDE IN PLASTIC CONTAINER	2MEQ/ML	INJECTABLE / INJECTION	AP	1985-01-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A088901-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088901-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088901-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088901-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088901-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088901-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088901-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088901-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088901-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088901-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088901-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088901-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088901-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088901-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088901-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088901-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088901-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088901-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088901-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088901-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088901-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088901-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088901-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088901-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088901-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088901-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088901-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088901-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088901-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088901-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088901-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088901-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088901-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088901-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088901-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088901-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088901-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088901-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088901-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088901-001	AP	1	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Henry Schein, Inc.	bf8e8ac7-e6a8-4571-a0ea-7bcab89290f6	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088901 application number: ANDA088901 ndc (product): 0404-9936
Potassium Chloride	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	fcd4f458-ce27-417e-9bb6-de1cc49d44b9	2023-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088901 application number: ANDA088901 ndc (product): 63323-965

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9936	Potassium Chloride	Potassium Chloride	Henry Schein, Inc.	ANDA	Current
0404-9936	Potassium Chloride	Potassium Chloride	Henry Schein, Inc.	ANDA	Current
52584-965	POTASSIUM CHLORIDE	potassium chloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-965	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-965	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-965	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-965	POTASSIUM CHLORIDE	potassium chloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-965	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-965	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-965	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-965	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-965	POTASSIUM CHLORIDE	potassium chloride	General Injectables & Vaccines, Inc.	ANDA	Current
63323-965	Potassium Chloride	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-965	Potassium Chloride	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-965	Potassium Chloride	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current