Application 021569

Type: NDA
Sponsor: LIEBEL-FLARSHEIM

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	INJECTABLE;INJECTION	405MG/50ML (9MG/ML)	Yes	No
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	1012.5MG/125ML (9MG/ML)	Yes	No

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

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
N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION		RLD	2006-07-27
N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION		RLD	2006-07-27

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1.125GM/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021569-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	405MG/50ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021569-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	1012.5MG/125ML (9MG/ML)	INJECTABLE / INJECTION	RLD	2006-07-27	`bb7c543d1eb4…`

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	Liebel-Flarsheim Company LLC	e4540d03-06b4-4b4d-b859-75c13e5c20dd	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021569 application number: NDA021569 ndc (product): 0019-1188

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
0019-1188	SODIUM CHLORIDE	sodium chloride	Liebel-Flarsheim Company LLC	NDA	Current
0019-1188	SODIUM CHLORIDE	sodium chloride	Liebel-Flarsheim Company LLC	NDA	Current
0019-1188	SODIUM CHLORIDE	sodium chloride	Liebel-Flarsheim Company LLC	NDA	Current
0019-1188	SODIUM CHLORIDE	sodium chloride	Liebel-Flarsheim Company LLC	NDA	Current
0019-1188	SODIUM CHLORIDE	sodium chloride	Liebel-Flarsheim Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57109	SUPPL	2019-01-03
57097	SUPPL	2019-01-02
5754	SUPPL	2012-03-12
15794	SUPPL	2012-03-06
37249	SUPPL	2009-10-16
37248	SUPPL	2008-06-12
5753	SUPPL	2008-04-30
21738	ORIG	2007-09-11
37247	ORIG	2006-08-04
5752	ORIG	2006-08-04