Application 017648

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	150MG/100ML;900MG/100ML	Yes	No
002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	300MG/100ML;900MG/100ML	Yes	No
003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	224MG/100ML;900MG/100ML	Yes	No
004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	75MG/100ML;900MG/100ML	No	No
005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	150MG/100ML;450MG/100ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982
N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982
N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	POTASSIUM CHLORIDE; SODIUM CHLORIDE	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017648-001	AP
N017648-002	AP
N017648-005	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 6 · 215 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	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-001	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%	150MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-002	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	300MG/100ML;900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-003	POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%	224MG/100ML;900MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-004	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%	75MG/100ML;900MG/100ML	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-005	POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%	150MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2002-11-26	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 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	N017648-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017648-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017648-005	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017648-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017648-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017648-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017648-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017648-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017648-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017648-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017648-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017648-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017648-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017648-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017648-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017648-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017648-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017648-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017648-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017648-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017648-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017648-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017648-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017648-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017648-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017648-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017648-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017648-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017648-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017648-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017648-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017648-001	AP	1	`301d65b070ca…`

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	POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Company	becc7410-0a25-49f5-b0c3-240078479dc8	2019-01-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017648 application number: NDA017648 ndc (product): 0338-0704 ndc (product): 0338-0691 ndc (product): 0338-0695

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0691	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0691	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0691	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0691	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0695	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0695	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0695	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0695	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0704	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0704	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0704	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0704	Potassium Chloride in Sodium Chloride	Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57352	SUPPL	2019-01-28
57256	SUPPL	2019-01-18
33326	SUPPL	2005-08-31
673	SUPPL	2005-08-31
33325	SUPPL	2005-05-25
672	SUPPL	2005-05-25
13876	SUPPL	2003-01-10
13875	ORIG	2002-11-26