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 44.

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 2 of 3 · 116 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1984-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019217-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	45MG/5ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019217-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	RLD	1998-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019217-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	360MG/40ML (9MG/ML)	SOLUTION / INJECTION	RLD	1999-04-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019217-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	RLD	1984-07-13	`b00525d2431f…`

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 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nacl 0.9% Normal Saline Solution	SODIUM CHLORIDE	CHI FUNG TECHNOLOGY COMPANY	5a53c4c8-c9de-700c-e063-6394a90a3ab5	2026-08-31	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	YYBA CORP	597f3347-647c-3545-e063-6294a90abab2	2026-08-20	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Hypertonic Saline	SODIUM CHLORIDE	NAVEH PHARMA (1996) LTD	167c7a9c-1228-4fb2-a89c-d3e148386323	2026-07-30	Warnings	Name fallback generic name: SODIUM CHLORIDE
Hypertonic Saline Solution Sodium Chloride	SODIUM CHLORIDE	NAVEH PHARMA (1996) LTD	750ea4b1-de2b-4299-aaa2-331daf383d0d	2026-07-30	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Medical Care de Mexico, S.A. de C.V.	9a1220fb-6853-45ae-838c-10d8596e1af7	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Fresenius Medical Care Renal Therapies Group, LLC	af5cdf1a-19f4-11e2-892e-0800200c9a66	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	LABORATORIOS GRIFOLS SA	eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
WHWSWB 0.9% Saline	SODIUM CHLORIDE	Yiwu Huanshu E-commerce Co., Ltd	4e9c21e5-f2f9-90e4-e063-6394a90acfe2	2026-07-11	Warnings	Name fallback generic name: SODIUM CHLORIDE
WHWSWB 0.9% SALINE	SODIUM CHLORIDE	Yiwu Huanshu E-commerce Co., Ltd	5082b773-79b2-2501-e063-6394a90a170f	2026-07-11	Warnings	Name fallback generic name: SODIUM CHLORIDE
SALINE NASAL	SODIUM CHLORIDE	ALAINA HEALTHCARE PRIVATE LIMITED	ed30a7f9-7132-42da-9bed-63a9b1c80ab2	2026-07-07	Warnings	Name fallback generic name: SODIUM CHLORIDE
0.9% Sodium Chloride Saline Solution	SODIUM CHLORIDE	Yunqi Cosmetics (Shenzhen) Co., Ltd	546af257-dbd1-11fc-e063-6394a90a8e0a	2026-06-16	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Cardinal Health 107, LLC	107af8bc-b6af-4b85-8c8a-ea757dcef1da	2026-06-12	Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
SALINE CLEANING	SODIUM CHLORIDE	Guangzhou Huanmei Cosmetics Co., Ltd.	524f07cc-ddb9-dda5-e063-6394a90ac0a5	2026-05-21	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	a2a964f7-c3ec-4dfb-e3a0-6d8136a80397	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Sportpharm LLC	a2c111f6-74d5-4a5d-82ac-d0f237488cb8	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride	SODIUM CHLORIDE	Method Pharmaceuticals, LLC	4b08859e-65bd-8255-e063-6394a90af614	2026-04-23	Warnings	Name fallback generic name: SODIUM CHLORIDE
SODIUM CHLORIDE 1 GRAM	SODIUM CHLORIDE	Gendose Pharmaceuticals, LLC	ce988ae5-61c6-4324-90e1-a94c8a54d0d0	2026-04-13	Warnings	Name fallback generic name: SODIUM CHLORIDE
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Walgreen Company	bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d	2026-04-06	Warnings	Name fallback generic name: SODIUM CHLORIDE
Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Hanlim	4ee80e16-1bb1-8238-e063-6294a90aa719	2026-04-04	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