Application 017641

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE;INJECTION20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N017641-001LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017641-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017641-001LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017641-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017641-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017641-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017641-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017641-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017641-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017641-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017641-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017641-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017641-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017641-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017641-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017641-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017641-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017641-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017641-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017641-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017641-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017641-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017641-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017641-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N017641-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017641-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017641-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017641-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N017641-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017641-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017641-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017641-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017641-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017641-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017641-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017641-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017641-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017641-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017641-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017641-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017641-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017641-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017641-001AP1cb3db0bc1861…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 017641
application number: NDA017641
ndc (product): 0990-7953
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 017641
application number: NDA017641
ndc (product): 51662-1516
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.afac6cc5-1ced-4639-b6f6-86f40ef5c30e2020-10-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 017641
application number: NDA017641
ndc (product): 76420-129

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEHospira, Inc.NDACurrent
0409-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEHospira, Inc.NDACurrent
0409-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEHospira, Inc.NDACurrent
0990-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.NDACurrent
0990-7953Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEICU Medical Inc.NDACurrent
51662-1300LACTATED RINGERSSODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1300LACTATED RINGERSSODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1300LACTATED RINGERSSODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1331RINGERSSODIUM LACTATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1331RINGERSSODIUM LACTATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1331RINGERSSODIUM LACTATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1516LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
76420-129Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDEAsclemed USA, Inc.NDACurrent