FDA.reportPublic FDA data

Application 019217

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION9MG/MLYesNo
002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDESOLUTION;INJECTION45MG/5ML (9MG/ML)YesNo
003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDESOLUTION;INJECTION90MG/10ML (9MG/ML)YesNo
004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDESOLUTION;INJECTION360MG/40ML (9MG/ML)YesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USESODIUM CHLORIDE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-13
N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18
N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18
N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-1384e616aacf4f…
2026-09-14 22:38:342026-08N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-0184e616aacf4f…
2026-08-18 06:07:402026-07N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019217-001SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1984-07-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019217-002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER45MG/5ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019217-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER90MG/10ML (9MG/ML)SOLUTION / INJECTIONRLD1998-11-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019217-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER360MG/40ML (9MG/ML)SOLUTION / INJECTIONRLD1999-04-015bbf6a4d5a75…

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 4 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsName fallback
generic name: SODIUM CHLORIDE
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Name fallback
generic name: SODIUM CHLORIDE
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyca3355f2-2cf0-4f58-bed5-0c4c0a7d35112025-10-08Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
QUALITY CHOICE SALINESODIUM CHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f51491d8-12ad-4b1b-a171-c621bfdcc3412025-08-12WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.e0466bb3-6c26-4044-b051-69f48b67f6322025-08-07Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation9e72418a-376e-4637-99ad-d13c904a79862025-07-30Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDENextgen Pharmaceuticals LLC28f79c75-82d2-4912-81fc-a723b5ccf4c12025-07-23Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEProPharma Distribution3868864f-4f46-d2a1-e063-6394a90a65d52025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.0d59a04a-32e6-485b-b638-a1e6c09e96422025-07-09Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium Chloride Normal SaltSODIUM CHLORIDEAdvanced Rx LLC40f471b7-27cf-4ad4-aef6-cc9d0623ddd92025-07-02WarningsName fallback
generic name: SODIUM CHLORIDE
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC6d43fa91-0940-437f-ba70-b2d3f977593e2025-04-25Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Nat Mur 6XSODIUM CHLORIDEHyland's Inc.dcf0e2ac-3b69-3ae4-e053-2a95a90aaf412025-04-10WarningsName fallback
generic name: SODIUM CHLORIDE
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsName fallback
generic name: SODIUM CHLORIDE
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsName fallback
generic name: SODIUM CHLORIDE
Natrum Muriaticum 6XSODIUM CHLORIDESEVENE USAff0d279e-210a-6f8a-e053-6294a90a11dc2025-02-11WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsName 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
DocumentSubmission typeDate
1254SUPPL2003-12-11