FDA.reportPublic FDA data

Potassium Chloride in Lactated Ringers and Dextrose

Product NDC
0338-0811
11-digit product format
003380811
Labeler code
0338
Product ID
0338-0811_127c3c05-ab6d-4c6c-84f9-9552f450f58b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA019367
Marketing category
NDA
Marketing start
1985-04-05
Substance
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength
20; 5; 179; 600; 310 mg/100mL; g/100mL; 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], 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
N019367-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05
N019367-002POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05
N019367-003POTASSIUM 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 / INJECTION1985-04-05
N019367-004POTASSIUM 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 / INJECTIONAP1985-04-05
N019367-005POTASSIUM 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 / INJECTIONAP1985-04-05
N019367-006POTASSIUM 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 / INJECTIONAP1985-04-05
N019367-007POTASSIUM 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 / INJECTIONAP1985-04-05
N019367-008POTASSIUM 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 / INJECTIONAP1985-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N019367-004AP
N019367-005AP
N019367-006AP
N019367-007AP
N019367-008AP

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 06:07:402026-07N019367-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-002POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-003POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-004POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-005POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-006POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-007POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-008POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019367-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-002POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-003POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-004POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-005POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-006POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-007POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-008POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-002POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-003POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-004POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-005POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-006POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-007POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-008POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019367-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-002POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-003POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-004POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-005POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-006POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-007POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-008POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-001POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-002POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-003POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION1985-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-004POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-005POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-006POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-007POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-008POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP1985-04-05fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019367-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-007AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019367-008AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019367-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-007AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019367-008AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-007AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019367-008AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019367-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-007AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019367-008AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-007AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019367-008AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019367-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019367-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019367-006AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019367-007AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019367-008AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019367-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019367-005AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019367-006AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019367-007AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019367-008AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019367-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019367-005AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019367-006AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019367-007AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019367-008AP12680178bc6a6…

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
DEXTROSE MONOHYDRATE20 mg/100mL
SODIUM CHLORIDE5 g/100mL
SODIUM LACTATE179 mg/100mL
POTASSIUM CHLORIDE600 mg/100mL
CALCIUM CHLORIDE310 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LX22YL083GInternal UNII lookup
451W47IQ8XInternal UNII lookup
TU7HW0W0QTInternal UNII lookup
660YQ98I10Internal UNII lookup
M4I0D6VV5MInternal 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
05f326e6-10e4-4ceb-8a23-f53c592f00b8Available 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
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0811-04Potassium Chloride in Lactated Ringers and Dextrose1000 mL in 1 BAGINJECTION, SOLUTION100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0811-04ML - Milliliter0338-081175d8a239-6d78-4266-a647-9012a4cbf0ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CHLORIDEACTIVE INGREDIENTM4I0D6VV5MPOTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GPOTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XPOTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
SODIUM LACTATEACTIVE INGREDIENTTU7HW0W0QTPOTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKPOTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
CHLORIDE IONACTIVE MOIETYQ32ZN48698POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
LACTIC ACIDACTIVE MOIETY33X04XA5ATPOTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RPOTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0811POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 1 package rows20240919_05f326e6-10e4-4ceb-8a23-f53c592f00b8.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 DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 019367
application number: NDA019367
ndc (product): 0338-0811

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847626potassium chloride 20 MEQ/L in lactated Ringers solution with dextrose 5 % Injectable SolutionPSN05f326e6-10e4-4ceb-8a23-f53c592f00b816
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 SolutionSCD05f326e6-10e4-4ceb-8a23-f53c592f00b816
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 SolutionSY05f326e6-10e4-4ceb-8a23-f53c592f00b816
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 SolutionSY05f326e6-10e4-4ceb-8a23-f53c592f00b816
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 SolutionSY05f326e6-10e4-4ceb-8a23-f53c592f00b816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0811-04003380811041000 mL in 1 BAG (0338-0811-04) 1000 ml1985-04-050000-00-00NoNoCurrent