Application 021703

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	No
002	PRISMASOL BGK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
003	PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
004	PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
005	PRISMASOL BGK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
006	PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
007	PRISMASOL BK 0/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
008	PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
009	PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	No	No
010	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	Yes	No
011	PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	Yes	Yes
012	PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	No	No
013	PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	Yes	No
014	PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes
015	PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 15 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021703-001	PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2006-10-25
N021703-002	PRISMASOL BGK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25
N021703-003	PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25
N021703-004	PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25
N021703-005	PRISMASOL BGK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25
N021703-006	PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25
N021703-007	PRISMASOL BK 0/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25
N021703-008	PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25
N021703-009	PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25
N021703-010	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2008-10-10
N021703-011	PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10
N021703-012	PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION		2008-10-10
N021703-013	PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2008-10-10
N021703-014	PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10
N021703-015	PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10

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 16 · 615 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021703-001	PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-002	PRISMASOL BGK 2/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-003	PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-004	PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-005	PRISMASOL BGK 4/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-006	PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-007	PRISMASOL BK 0/0 IN PLASTIC CONTAINER	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-008	PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-009	PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-010	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2008-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-011	PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-012	PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION		2008-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-013	PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2008-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-014	PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021703-015	PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-001	PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-002	PRISMASOL BGK 2/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-003	PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-004	PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-005	PRISMASOL BGK 4/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-006	PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-007	PRISMASOL BK 0/0 IN PLASTIC CONTAINER	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-008	PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-009	PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-010	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2008-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-011	PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-012	PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION		2008-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-013	PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2008-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-014	PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021703-015	PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2008-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021703-001	PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-002	PRISMASOL BGK 2/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-003	PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-004	PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-005	PRISMASOL BGK 4/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-006	PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD, RS	2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-007	PRISMASOL BK 0/0 IN PLASTIC CONTAINER	N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-008	PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER	5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-009	PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER	3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)	INJECTABLE / INJECTION		2006-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021703-010	PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER	N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)	INJECTABLE / INJECTION	RLD	2008-10-10	`6a471c1ec25d…`

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
PRISMASOL BGK2/0	MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE	Vantive US Healthcare LLC	7f675fee-8940-4ece-bb0c-75ac79d8708c	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021703 application number: NDA021703 ndc (product): 24571-114 ndc (product): 24571-111 ndc (product): 24571-103 ndc (product): 24571-113 ndc (product): 24571-108 ndc (product): 24571-102 ndc (product): 24571-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-102	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-103	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-105	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-108	PRISMASOL	calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-111	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-113	PRISMASOL	magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current
24571-114	PRISMASOL	magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate and potassium chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74160	SUPPL	2023-05-03
74157	SUPPL	2023-05-03
56244	SUPPL	2018-12-06
56295	SUPPL	2018-11-06
48905	SUPPL	2017-07-05
48890	SUPPL	2017-07-03
6021	SUPPL	2016-07-22
37490	SUPPL	2016-07-21
37489	SUPPL	2015-12-17
28415	SUPPL	2015-12-17
28414	SUPPL	2013-06-12
16228	SUPPL	2012-04-17
6020	SUPPL	2012-04-16
16227	SUPPL	2009-04-28
37488	SUPPL	2008-11-07
28413	SUPPL	2008-10-22
42276	ORIG	2008-04-22
28412	ORIG	2006-10-27
16226	ORIG	2006-10-26