Application 080205

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2MEQ/ML	No	Yes
003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	1MEQ/ML	No	No
004	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2.4MEQ/ML	No	No
005	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	3.2MEQ/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A080205-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
A080205-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982
A080205-004	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982
A080205-005	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080205-001	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080205-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080205-003	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080205-004	POTASSIUM CHLORIDE	2.4MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080205-005	POTASSIUM CHLORIDE	3.2MEQ/ML	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`

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	A080205-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080205-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080205-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080205-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080205-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080205-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080205-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080205-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080205-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080205-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080205-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080205-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080205-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080205-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080205-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080205-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080205-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080205-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080205-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080205-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080205-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080205-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080205-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080205-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080205-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080205-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080205-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080205-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080205-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080205-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080205-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080205-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080205-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080205-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080205-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080205-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080205-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080205-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080205-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080205-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	559a0a8c-a8fe-40a5-b196-21f9308780ab	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205 ndc (product): 0409-6653 ndc (product): 0409-6635 ndc (product): 0409-6651
Potassium Chloride	POTASSIUM CHLORIDE	Henry Schein, Inc.	8367a2ae-dfd9-4515-838c-529920291ca0	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205 ndc (product): 0404-9937
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9508355e-e1ed-412b-e053-2a95a90aac8e	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205 ndc (product): 51662-1387
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	951ffdc3-d54f-d5e1-e053-2a95a90a79e6	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080205 application number: ANDA080205 ndc (product): 51662-1421

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9937	Potassium Chloride	Potassium Chloride	Henry Schein, Inc.	ANDA	Current
0404-9937	Potassium Chloride	Potassium Chloride	Henry Schein, Inc.	ANDA	Current
0409-6635	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6635	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6635	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6635	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6651	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6651	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6651	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6651	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6653	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6653	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6653	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
0409-6653	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Hospira, Inc.	ANDA	Current
51662-1387	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1387	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1421	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1421	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-651	Potassium Chloride	Potassium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-651	Potassium Chloride	Potassium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-651	Potassium Chloride	Potassium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-651	Potassium Chloride	Potassium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-651	Potassium Chloride	Potassium Chloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-653	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-653	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-653	Potassium Chloride	Potassium Chloride	General Injectables & Vaccines, Inc	ANDA	Current
55154-2367	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Cardinal Health	ANDA	Current
55154-6999	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Cardinal Health	ANDA	Current