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 6 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	e5e325d1-0d58-40c9-9645-3ae402ff9d92	2024-10-11	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	cc3d5bc8-9d3c-4c65-9e43-707a2db4081a	2024-09-25	Warnings	Name fallback generic name: SODIUM CHLORIDE
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	93fafa27-5031-4d95-b4b8-5574b7204ae2	2024-09-25	Warnings	Name fallback generic name: SODIUM CHLORIDE
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	454f337e-d897-46de-ab05-1c543a33061c	2024-09-25	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	f55bd888-5e01-474d-871b-24654c070178	2024-07-24	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	83994d0c-8484-4505-abb5-8a384ed12288	2024-07-22	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	8df7dcf6-8714-6caf-e053-2995a90ab8cc	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	CODAN US CORPORATION	aa06e286-75c6-4d7a-959f-6008d38aa6e5	2024-06-24	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	239a5af1-7498-480f-862c-ab7c3d89d183	2024-05-21	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ebc8b008-a8b3-4c41-89e4-b413f7aab89f	2024-05-21	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	47a0313f-36df-4fa6-a828-c9e1946ba9b0	2024-05-08	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	7f22c06b-6b4d-4b49-a4b2-d2169f2bd653	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	f2475fa3-ab1d-4b81-8127-b58cd0790a54	2024-05-06	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c1e52670-c85e-4f19-a2e9-bf9abd7c3727	2024-04-23	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Hikma Pharmaceuticals USA Inc.	e5ee8caa-b6ca-45ba-98fb-8305e6282141	2024-04-10	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
CVS Health Sterile Saline Mist	SODIUM CHLORIDE	CVS Pharmacy	14931004-1efb-e331-e063-6294a90ad66e	2024-03-26	Warnings	Name fallback generic name: SODIUM CHLORIDE
Aqua marina	SODIUM CHLORIDE	Boiron	14945760-30b5-27d3-e063-6394a90a8a32	2024-03-26		Name fallback generic name: SODIUM CHLORIDE
Natrum Muriaticum	SODIUM CHLORIDE	SEVENE USA	11008014-fff6-4d5a-8c5c-a20443d7cc23	2024-01-30	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Spectra Medical Deviecs, LLC	7e316d21-d6ad-4976-bd90-268fd7e51361	2024-01-12	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	037ac04d-f8f3-4bb8-993a-ac8f7683ff83	2024-01-04	Warnings, Adverse reactions	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