Application 018629

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 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;330MG/100ML	No	No
002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;330MG/100ML	No	No
003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;330MG/100ML	No	No
004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;150MG/100ML;330MG/100ML	No	No
005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;75MG/100ML;330MG/100ML	No	No
006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;330MG/100ML	No	No
007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;330MG/100ML	No	No
008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;300MG/100ML;330MG/100ML	No	No

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

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
N018629-001	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23
N018629-002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23
N018629-003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23
N018629-004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23
N018629-005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23
N018629-006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23
N018629-007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23
N018629-008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N018629-001	AP
N018629-002	AP
N018629-003	AP
N018629-004	AP
N018629-005	AP
N018629-006	AP
N018629-007	AP
N018629-008	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 · 344 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
2026-09-14 22:38:34	2026-08	N018629-001	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018629-001	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018629-001	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-001	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018629-001	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-002	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-003	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-004	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;150MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-005	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER	5GM/100ML;75MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-006	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-007	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	5GM/100ML;224MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-008	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER	5GM/100ML;300MG/100ML;330MG/100ML	INJECTABLE / INJECTION	AP	1982-03-23	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 344 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	N018629-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-007	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018629-008	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018629-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018629-008	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018629-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018629-008	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018629-008	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018629-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018629-008	AP	1	`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
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): 018629 application number: NDA018629 ndc (product): 0338-0603

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0603	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0603	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0603	Potassium Chloride in Dextrose and Sodium Chloride	Potassium Chloride, Dextrose Monohydrate and Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0603	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
58036	SUPPL	2019-03-19
57758	SUPPL	2019-02-22
54943	SUPPL	2018-07-23