Application 017634

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML	Yes	No
002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML	Yes	No
003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML	Yes	No
004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982
N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017634-001	AP
N017634-002	AP
N017634-004	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 4 of 5 · 176 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
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017634-001	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017634-002	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017634-003	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017634-004	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML	INJECTABLE / INJECTION	AP	RLD, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017634-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017634-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017634-004	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017634-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017634-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017634-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017634-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017634-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017634-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017634-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017634-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017634-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017634-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017634-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017634-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017634-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017634-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017634-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017634-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017634-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017634-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017634-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017634-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017634-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017634-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017634-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017634-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017634-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017634-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017634-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017634-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017634-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017634-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017634-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017634-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017634-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017634-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017634-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017634-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017634-001	AP	1	`79d66fd596c7…`

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 Dextrose	POTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	45de5402-5e61-4bbd-8bbc-5e3392c9920e	2019-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017634 application number: NDA017634 ndc (product): 0338-0683

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0683	Potassium Chloride in Dextrose	Potassium Chloride and Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0683	Potassium Chloride in Dextrose	Potassium Chloride and Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0683	Potassium Chloride in Dextrose	Potassium Chloride and Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0683	Potassium Chloride in Dextrose	Potassium Chloride and Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0683	Potassium Chloride in Dextrose	Potassium Chloride and Dextrose Monohydrate	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59349	SUPPL	2019-07-16
59339	SUPPL	2019-07-16
48608	SUPPL	2017-05-31
48607	SUPPL	2017-05-31
48595	SUPPL	2017-05-31
48594	SUPPL	2017-05-31
33323	SUPPL	2015-01-09
13873	SUPPL	2014-12-24
33322	SUPPL	2005-08-31
669	SUPPL	2005-08-31
33321	SUPPL	2005-05-25
668	SUPPL	2005-05-25
13872	SUPPL	2004-06-02