Application 019367

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	No	No
002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	No	No
003	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	No	No
004	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	No	No
005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	No	No
006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	No	No
007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	No	No
008	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N019367-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05
N019367-002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05
N019367-003	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05
N019367-004	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05
N019367-005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05
N019367-006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05
N019367-007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05
N019367-008	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N019367-004	AP
N019367-005	AP
N019367-006	AP
N019367-007	AP
N019367-008	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 9 · 336 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
2026-08-18 06:07:40	2026-07	N019367-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-003	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-004	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-008	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019367-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-003	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-004	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-008	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-003	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-004	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-008	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019367-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-003	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-004	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-008	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-001	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-003	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION		1985-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-004	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-008	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML	INJECTABLE / INJECTION	AP	1985-04-05	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	N019367-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019367-008	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019367-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019367-008	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019367-008	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019367-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019367-008	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019367-008	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019367-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019367-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019367-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019367-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019367-008	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019367-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019367-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019367-006	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019367-007	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019367-008	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019367-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019367-005	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019367-006	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019367-007	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019367-008	AP	1	`2680178bc6a6…`

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 Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	05f326e6-10e4-4ceb-8a23-f53c592f00b8	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019367 application number: NDA019367 ndc (product): 0338-0811

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0811	Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84117	SUPPL	2025-11-06
84077	SUPPL	2025-11-06
60527	SUPPL	2020-01-23
60515	SUPPL	2019-10-10
50641	SUPPL	2017-12-07
50640	SUPPL	2017-12-07
11481	SUPPL	2011-11-04
1294	SUPPL	2011-10-24
33728	SUPPL	2005-08-31
1293	SUPPL	2005-08-31
17363	SUPPL	2005-06-08
11480	SUPPL	2005-06-08
17362	SUPPL	2003-01-03