Application 019022

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	3GM/100ML	Yes	Yes
002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01
N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	SODIUM CHLORIDE	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019022-001	AP
N019022-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019022-001	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-11-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019022-002	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP	RLD	1983-11-01	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019022-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019022-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019022-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019022-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019022-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019022-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019022-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019022-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019022-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019022-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019022-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019022-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019022-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019022-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019022-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019022-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019022-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019022-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019022-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019022-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019022-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019022-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019022-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019022-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019022-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019022-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019022-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019022-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019022-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019022-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019022-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019022-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019022-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019022-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019022-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019022-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019022-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019022-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019022-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019022-002	AP	1	`782e0a99824c…`

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	181705c7-40e4-4d7d-b9ea-ada99380e7a9	2018-05-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019022 application number: NDA019022 ndc (product): 0338-0056 ndc (product): 0338-0054

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0054	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0054	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0054	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0054	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0054	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0056	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0056	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0056	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0056	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0056	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55511	SUPPL	2018-09-18
55499	SUPPL	2018-09-18
33690	SUPPL	2015-01-08
1206	SUPPL	2014-12-30
16176	SUPPL	2005-08-31
11417	SUPPL	2005-08-31
11416	SUPPL	2005-06-14
1205	SUPPL	2005-06-14
1204	SUPPL	2002-04-03