Application 019635

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	450MG/100ML	Yes	No
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	Yes	Yes
003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	3GM/100ML	No	No
004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML	No	No
005	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/10ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09
N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09
N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09
N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	SODIUM CHLORIDE	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09
N019635-005	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N019635-001	AP
N019635-002	AP
N019635-003	AP
N019635-004	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 6 · 210 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
2026-08-18 06:07:40	2026-07	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	RLD	1988-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-003	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-004	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	INJECTABLE / INJECTION	AP		1988-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-005	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION		RLD	2016-08-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	N019635-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019635-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019635-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019635-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019635-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019635-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019635-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019635-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019635-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019635-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019635-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019635-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019635-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019635-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019635-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019635-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019635-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019635-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019635-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019635-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019635-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019635-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019635-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019635-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019635-004	AP	1	`d8e5a09893c0…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	47a0313f-36df-4fa6-a828-c9e1946ba9b0	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019635 application number: NDA019635 ndc (product): 0264-7800
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	7f22c06b-6b4d-4b49-a4b2-d2169f2bd653	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019635 application number: NDA019635 ndc (product): 0264-7802 ndc (product): 0264-7800
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	f2475fa3-ab1d-4b81-8127-b58cd0790a54	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019635 application number: NDA019635 ndc (product): 0264-7806 ndc (product): 0264-7805
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	24a08a93-df23-474b-873e-c59ec8855f9f	2022-03-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019635 application number: NDA019635 ndc (product): 0264-9375
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	e44c41ae-c9c8-4dd8-ba6c-cebb585378aa	2022-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019635 application number: NDA019635 ndc (product): 0264-5802 ndc (product): 0264-5804

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-5802	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-5804	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7800	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7802	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7802	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7802	Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	NDA	Current
0264-7805	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7805	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7806	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7806	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-9375	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-9375	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11574	SUPPL	2014-09-09