Application 016366

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION900MG/100MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N016366-001AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016366-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N016366-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016366-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016366-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016366-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016366-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016366-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016366-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016366-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016366-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016366-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016366-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016366-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016366-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016366-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016366-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016366-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016366-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016366-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016366-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016366-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016366-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016366-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N016366-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016366-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016366-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016366-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N016366-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N016366-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016366-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016366-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016366-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016366-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016366-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016366-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016366-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N016366-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N016366-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016366-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016366-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016366-001AP1e64feba35796…

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.5f372b75-d7a4-471e-8ac6-290040fc84b02025-11-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 016366
application number: NDA016366
ndc (product): 0990-7984
ndc (product): 0990-7983
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstac0fd44a-3f39-8d7e-e053-2995a90afeec2020-08-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 016366
application number: NDA016366
ndc (product): 51662-1522
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta62b71db-8ba2-6f6b-e053-2a95a90a29d12020-05-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 016366
application number: NDA016366
ndc (product): 51662-1520
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2b8220f-e33a-51c3-e053-2995a90a07342020-04-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 016366
application number: NDA016366
ndc (product): 51662-1517
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2bba76a-08ce-6902-e053-2995a90ab9c92020-04-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 016366
application number: NDA016366
ndc (product): 51662-1518

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7983Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7983Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7983Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7983Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7984Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7984Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7984Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0409-7984Sodium ChlorideSODIUM CHLORIDEHospira, Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7983Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7984Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.NDACurrent
51662-1258SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1258SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1258SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-12600.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-12600.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-12600.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-13080.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-13080.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-13080.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1318SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1318SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1318SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-15170.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-15180.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-15200.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1522SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49834SUPPL2017-09-22
49831SUPPL2017-09-22