Application 019319

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION FOR SLUSH;IRRIGATION	900MG/100ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		RLD, RS	1985-05-17

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 2 · 41 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	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION		1985-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019319-002	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	SOLUTION FOR SLUSH / IRRIGATION	RLD, RS	1985-05-17	`cb3db0bc1861…`

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
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	7c72520e-de3c-493d-8aea-11933376d968	2018-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019319 application number: NDA019319 ndc (product): 0338-0051

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
0338-0051	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0051	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0051	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0051	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current