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 5 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Sterile Saline Mist	SODIUM CHLORIDE	WALMART INC.	275ada29-8904-fe1e-e063-6394a90abe59	2025-01-24	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	93aeac13-41de-4452-9f38-d6b4f38ada30	2025-01-24		Name fallback generic name: SODIUM CHLORIDE
D-129	SODIUM CHLORIDE	DNA Labs, Inc.	ef130f08-1c34-4774-9298-2d1997e631fc	2025-01-13	Warnings	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	998a2a47-5c79-2efd-e053-2995a90a8fac	2025-01-08	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7da788fc-3481-527f-e053-2a91aa0af6ac	2025-01-08	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
DG Health Sterile Saline Mist	SODIUM CHLORIDE	DG Health	f2e44ab4-ae0f-c87b-e053-2a95a90acd04	2024-12-31	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sterile Hypertonic Saline Solution 7 Sodium Chloride	SODIUM CHLORIDE	JOONEM LLC	e7110525-9f9b-5b68-e053-2995a90ac034	2024-12-23	Warnings	Name fallback generic name: SODIUM CHLORIDE
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	49309411-9af4-4f19-a3bf-dbeabc106827	2024-12-23	Warnings	Name fallback generic name: SODIUM CHLORIDE
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	ba0868f6-d3de-40e2-bcb3-144fa53062c7	2024-12-23	Warnings	Name fallback generic name: SODIUM CHLORIDE
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	9d83f477-ebbc-4248-8445-769178181d4f	2024-12-23	Warnings	Name fallback generic name: SODIUM CHLORIDE
Ancient Secrets Breathe Again	SODIUM CHLORIDE	LOTUS BRANDS, INC.	c6d2bab0-d363-4c09-a71b-ae15db915b37	2024-12-18	Warnings	Name fallback generic name: SODIUM CHLORIDE
Walgreens Saline Mist Extra Strength	SODIUM CHLORIDE	Walgreen's Corporation	90cbe2dc-36b6-77fb-e053-2995a90a2897	2024-12-18	Warnings	Name fallback generic name: SODIUM CHLORIDE
CVS Health Sterile Saline Mist	SODIUM CHLORIDE	CVS Pharmacy	6f1fe980-ca09-401d-aed6-d3d3387cc49a	2024-12-18	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	464c2d78-5c88-4668-a039-56dd3c1c9b20	2024-12-03		Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	aaab14e7-a4b4-4b2b-8d73-ba688064a9b1	2024-11-21		Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	99a15716-bbb9-4e33-a48d-20c58b81f392	2024-11-13		Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	8eb172da-dcd4-4660-4a8f-ad44a14b4af7	2024-11-06	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Licefreee	SODIUM CHLORIDE	Tec Laboratories, Inc.	40b8dd81-fd8b-602e-e054-00144ff8d46c	2024-11-05	Warnings	Name fallback generic name: SODIUM CHLORIDE
Licefreee Everyday	SODIUM CHLORIDE	Tec Laboratories,Inc.	407b5fd6-2331-2ba7-e054-00144ff88e88	2024-11-05	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c44b0fdb-33df-4747-b443-5fb4deb456cb	2024-10-11	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