Application 018037

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;200MG/100ML	No	No
002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;200MG/100ML	No	No
003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;200MG/100ML	No	No
004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;200MG/100ML	No	No
005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;200MG/100ML	No	No
006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;200MG/100ML	No	No
007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;200MG/100ML	No	No
008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;200MG/100ML	No	No
009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;200MG/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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982
N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13
N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-product	TE code
N018037-001	AP
N018037-002	AP
N018037-003	AP
N018037-004	AP
N018037-005	AP
N018037-006	AP
N018037-007	AP
N018037-008	AP
N018037-009	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 10 · 378 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
2026-08-18 06:07:40	2026-07	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-005	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-006	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-007	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-008	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-009	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP		1982-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-001	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	5GM/100ML;300MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-002	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ	5GM/100ML;75MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-003	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)	5GM/100ML;150MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-004	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	5GM/100ML;224MG/100ML;200MG/100ML	INJECTABLE / INJECTION	AP	Approved before 1982		`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 378 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	N018037-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018037-009	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018037-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018037-009	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018037-009	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018037-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018037-009	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018037-004	AP	1	`fd3edfee7708…`

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 and Sodium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018037 application number: NDA018037 ndc (product): 0338-0663

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0663	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0663	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0663	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0663	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58035	SUPPL	2019-03-19
57757	SUPPL	2019-02-22
808	SUPPL	2013-09-12
11131	SUPPL	2013-09-11
13995	SUPPL	2007-05-01
11130	SUPPL	2007-04-25
33405	SUPPL	2005-08-31
807	SUPPL	2005-08-31
13994	SUPPL	2004-06-07
806	SUPPL	2003-05-29