Application 019217

Type: NDA
Sponsor: ICU MEDICAL INC

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	9MG/ML	Yes	No
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	45MG/5ML (9MG/ML)	Yes	No
003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	90MG/10ML (9MG/ML)	Yes	No
004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	360MG/40ML (9MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13
N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18
N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18
N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01

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 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`5bbf6a4d5a75…`

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 7 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Altachlore Sodium Chloride Hypertonicity	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	dc0d94d8-4475-4956-8ded-bdb9496074e4	2023-12-09	Warnings	Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8646d7ea-cf5e-607d-e053-2a91aa0aeca1	2023-11-14		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86466121-7217-d053-e053-2a91aa0a8f8a	2023-11-14		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	864669c9-5bdc-232f-e053-2a91aa0a1fc6	2023-11-14		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86462e06-d221-36b7-e053-2991aa0a1d82	2023-11-14		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8644ffef-f0ec-5c06-e053-2a91aa0ae83d	2023-10-23		Name fallback generic name: SODIUM CHLORIDE
Aqua marina	SODIUM CHLORIDE	Boiron	6a212a52-32be-21b8-e053-2991aa0aea2f	2023-10-22		Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b6e33138-841a-471f-a934-c4086cbc23f6	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86455058-2722-5c0a-e053-2a91aa0ac659	2023-06-26		Name fallback generic name: SODIUM CHLORIDE
BACTERIOSTATIC SODIUM CHLORIDE	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	8a0d24a9-d02a-0379-e053-2a95a90af712	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	1ef4a040-7bee-11e6-8371-424c58303031	2023-02-20		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8645e304-a71b-5cba-e053-2a91aa0a2d88	2023-02-20		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86463b98-58f5-7f65-e053-2a91aa0ad3a2	2023-01-23		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8645f130-6a19-ae73-e053-2991aa0ab05b	2023-01-23		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8645eb60-65d1-9d6c-e053-2991aa0a94ef	2023-01-23		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	8644ffef-f0e6-5c06-e053-2a91aa0ae83d	2023-01-23		Name fallback generic name: SODIUM CHLORIDE
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86466614-b8ee-2335-e053-2a91aa0aa67c	2023-01-23		Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	Liebel-Flarsheim Company LLC	e4540d03-06b4-4b4d-b859-75c13e5c20dd	2022-12-20	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
NATRUM MURIATICUM	SODIUM CHLORIDE	Hyland's Inc.	21ee53eb-b41a-4d2e-8037-12973d2b73d9	2022-12-19	Warnings	Name fallback generic name: SODIUM CHLORIDE
CVS Health Sterile Saline Mist	SODIUM CHLORIDE	CVS Pharmacy	4df47f14-8268-4cd3-b29e-96446743e2f6	2022-12-16	Warnings	Name fallback generic name: SODIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1254	SUPPL	2003-12-11