FDA.reportPublic FDA data

Potassium Chloride in Lactated Ringers and Dextrose

Product NDC
0990-7111
11-digit product format
009907111
Labeler code
0990
Product ID
0990-7111_fb53b802-9589-46e1-b404-b51c4ac61f5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA019685
Marketing category
NDA
Marketing start
2019-11-25
Substance
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength
.2; 50; 1.79; 6; 3.1 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL
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], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019685-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17
N019685-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPRLD1988-10-17
N019685-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17
N019685-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17
N019685-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17
N019685-006POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17
N019685-007POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17
N019685-008POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019685-002AP

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 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019685-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019685-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPRLD1988-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019685-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019685-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019685-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019685-006POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019685-007POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019685-008POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019685-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019685-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPRLD1988-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019685-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019685-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019685-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019685-006POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019685-007POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019685-008POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPRLD1988-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-006POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-007POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-008POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019685-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019685-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPRLD1988-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019685-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019685-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019685-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019685-006POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019685-007POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019685-008POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAPRLD1988-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-005POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-006POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-007POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-008POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONRLD1988-10-17fd3edfee7708…

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 06:07:402026-07N019685-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019685-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019685-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019685-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019685-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019685-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019685-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019685-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019685-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019685-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019685-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019685-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019685-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019685-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019685-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019685-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019685-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019685-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019685-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019685-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019685-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019685-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019685-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019685-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019685-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019685-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019685-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019685-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019685-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019685-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019685-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019685-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019685-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019685-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019685-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019685-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019685-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019685-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019685-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019685-002AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride in Lactated Ringers and Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE.2 g/1000mL
SODIUM CHLORIDE50 g/1000mL
CALCIUM CHLORIDE1.79 g/1000mL
SODIUM LACTATE6 g/1000mL
DEXTROSE MONOHYDRATE3.1 g/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
660YQ98I10Internal UNII lookup
451W47IQ8XInternal UNII lookup
M4I0D6VV5MInternal UNII lookup
TU7HW0W0QTInternal UNII lookup
LX22YL083GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
847626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
237b39fa-916e-4a54-99c8-4ae9ad54f056Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7111-09Potassium Chloride in Lactated Ringers and Dextrose1 in 1 POUCHINJECTION, SOLUTION113
0990-7111-09Potassium Chloride in Lactated Ringers and Dextrose12 in 1 CASEINJECTION, SOLUTION1213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7111-09ML - Milliliter0990-711184577137-0165-4159-b82d-99f7927b555312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7111POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [ICU MEDICAL INC.]11Current NDC, Legacy NDC, 2 package rows20231201_237b39fa-916e-4a54-99c8-4ae9ad54f056.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 019685
application number: NDA019685
ndc (product): 0990-7111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847626potassium chloride 20 MEQ/L in lactated Ringers solution with dextrose 5 % Injectable SolutionPSN237b39fa-916e-4a54-99c8-4ae9ad54f05613
847626calcium chloride 0.2 MG/ML / glucose 50 MG/ML / potassium chloride 1.79 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCD237b39fa-916e-4a54-99c8-4ae9ad54f05613
847626calcium chloride 0.2 MG/ML / glucose 50 MG/ML / K+ chloride 1.79 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY237b39fa-916e-4a54-99c8-4ae9ad54f05613
847626calcium chloride 0.2 MG/ML / glucose 50 MG/ML / Pot chloride 1.79 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY237b39fa-916e-4a54-99c8-4ae9ad54f05613
847626calcium chloride 20 MG / potassium chloride 179 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringer's with dextrose 5 % Injectable SolutionSY237b39fa-916e-4a54-99c8-4ae9ad54f05613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7111-090099071110912 POUCH in 1 CASE (0990-7111-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG12 pouch2019-11-250000-00-00NoNoCurrent