FDA.reportPublic FDA data

Ringers Irrigation

Product NDC
0990-6140
11-digit product format
009906140
Labeler code
0990
Product ID
0990-6140_e3cc8c5f-dcf6-4de1-9a90-b696ad46bd4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Chloride, Potassium Chloride, and Calcium Chloride Irrigant
Dosage form
INJECTION, SOLUTION
Route
IRRIGATION
Labeler
ICU Medical Inc.
Application
NDA017635
Marketing category
NDA
Marketing start
2021-09-17
Marketing end
0000-00-00
Substance
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active strength
33 mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0990-6140DDiscontinued by firm2026-09-14
excluded packagepackage0990-61400990-6140-09DDiscontinued by firm2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N017635-001RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017635-001AT

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017635-001RINGER'S IN PLASTIC CONTAINER33MG/100ML;30MG/100ML;860MG/100MLSOLUTION / IRRIGATIONATApproved before 1982f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N017635-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N017635-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017635-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017635-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017635-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017635-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017635-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017635-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017635-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017635-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017635-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017635-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017635-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017635-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017635-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017635-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017635-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017635-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017635-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017635-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017635-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017635-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017635-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N017635-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017635-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017635-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017635-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N017635-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017635-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017635-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017635-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017635-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017635-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017635-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017635-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017635-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017635-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017635-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017635-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017635-001AT1f41ea6bd6efb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-6140-09ML - Milliliter0990-61408b10662c-6b3e-4ad4-82e9-1f20f60ac20e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-6140RINGERS IRRIGATION (SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE IRRIGANT) INJECTION, SOLUTION [ICU MEDICAL INC.]7Legacy NDC20241218_91517ea8-0767-4ef4-81c9-91b59ad8b2f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-6140-09009906140091000 mL in 1 BOTTLE (0990-6140-09) 1000 ml2021-09-170000-00-00NoNoCurrent