Application 019465

Type: NDA
Sponsor: HOSPIRA

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	900MG/100ML	Yes	Yes
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	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
N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15
N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019465-001	AP
N019465-002	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 · 84 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	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1985-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1985-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1985-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1985-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1985-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1985-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019465-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1985-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019465-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1985-07-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N019465-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019465-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019465-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019465-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019465-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019465-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019465-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019465-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019465-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019465-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019465-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019465-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019465-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019465-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019465-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019465-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019465-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019465-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019465-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019465-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019465-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019465-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019465-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019465-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019465-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019465-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019465-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019465-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019465-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019465-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019465-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019465-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019465-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019465-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019465-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019465-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019465-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019465-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019465-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019465-002	AP	1	`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	Hospira, Inc.	a2a964f7-c3ec-4dfb-e3a0-6d8136a80397	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019465 application number: NDA019465 ndc (product): 0409-7101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7101	Sodium Chloride	Sodium Chloride	Hospira, Inc.	NDA	Current
0409-7101	Sodium Chloride	Sodium Chloride	Hospira, Inc.	NDA	Current
0409-7101	Sodium Chloride	Sodium Chloride	Hospira, Inc.	NDA	Current
0409-7101	Sodium Chloride	Sodium Chloride	Hospira, Inc.	NDA	Current
0409-7101	Sodium Chloride	Sodium Chloride	Hospira, Inc.	NDA	Current
0409-7101	Sodium Chloride	Sodium Chloride	Hospira, Inc.	NDA	Current
0409-7101	Sodium Chloride	Sodium Chloride	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45482	SUPPL	2016-09-30
45428	SUPPL	2016-09-29
17413	SUPPL	2016-06-14