Application 016733

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;IRRIGATION	900MG/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N016733-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016733-001	AT

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N016733-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016733-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016733-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016733-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / IRRIGATION	AT	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N016733-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016733-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016733-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016733-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016733-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016733-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016733-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016733-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016733-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016733-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016733-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016733-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016733-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016733-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016733-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016733-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016733-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016733-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016733-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016733-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016733-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016733-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016733-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016733-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016733-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016733-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016733-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016733-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016733-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016733-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016733-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016733-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016733-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016733-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016733-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016733-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016733-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016733-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016733-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016733-001	AT	1	`3a93d1ddd44b…`

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 · 2 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.	0d59a04a-32e6-485b-b638-a1e6c09e9642	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016733 application number: NDA016733 ndc (product): 0264-2201
Sodium Chloride for Irrigation	SODIUM CHLORIDE FOR IRRIGATION	B. Braun Medical Inc.	5bd9b176-0402-4a3f-a6b4-c3f393fc092a	2021-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016733 application number: NDA016733 ndc (product): 0264-7388

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-2201	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-2201	Sodium Chloride	Sodium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7388	Sodium Chloride for Irrigation	Sodium Chloride for Irrigation	B. Braun Medical Inc.	NDA	Current
0264-7388	Sodium Chloride for Irrigation	Sodium Chloride for Irrigation	B. Braun Medical Inc.	NDA	Current
61786-217	Sodium Chloride	Sodium Chloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85317	SUPPL	2026-03-10
85316	SUPPL	2026-03-10
489	SUPPL	2006-10-23