FDA.reportPublic FDA data

Lactated Ringers and Dextrose

Product NDC
65219-243
Requested package NDC
65219-243-50
11-digit product format
652190243
Labeler code
65219
Product ID
65219-243_b13e4afe-9bf1-4bf8-9674-e53ae5cb0fce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA210332
Marketing category
ANDA
Marketing start
2022-03-28
Substance
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength
20; 5; 30; 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 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
A210332-001DEXTROSE 5% AND LACTATED RINGER'SCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP2022-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210332-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP2022-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP2022-03-285d02ea3f76ae…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTION2022-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP2022-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP2022-03-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210332-001DEXTROSE 5% AND LACTATED RINGER'S20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE / INJECTIONAP2022-03-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210332-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210332-001AP15d02ea3f76ae…
2022-09-29 23:25 UTC2022-09A210332-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210332-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210332-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Lactated Ringers and Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE20 mg/100mL
SODIUM LACTATE5 g/100mL
POTASSIUM CHLORIDE30 mg/100mL
CALCIUM CHLORIDE600 mg/100mL
DEXTROSE MONOHYDRATE310 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TU7HW0W0QTInternal UNII lookup
LX22YL083GInternal UNII lookup
451W47IQ8XInternal 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
847627Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b912c7e-f005-4af4-b683-083440964249Available 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
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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
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
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d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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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
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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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-243-01Lactated Ringers and Dextrose500 mL in 1 BAGINJECTION, SOLUTION5005
65219-243-50Lactated Ringers and Dextrose20 in 1 CASEINJECTION, SOLUTION205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-243LACTATED RINGERS AND DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, 2 package rows20240524_1b912c7e-f005-4af4-b683-083440964249.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
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210332
application number: ANDA210332
ndc (package): 65219-243-50
ndc (product): 65219-243
ndc11 (package): 65219024350

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847627lactated Ringers with dextrose 5 % Injectable SolutionPSN1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 0.2 MG/ML / glucose 50 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCD1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 0.2 MG/ML / glucose 50 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 0.2 MG/ML / glucose 50 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringers with dextrose 5 % Injectable SolutionSY1b912c7e-f005-4af4-b683-0834409642495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-243-506521902435020 BAG in 1 CASE (65219-243-50) / 500 mL in 1 BAG (65219-243-01) 20 bag2022-12-22NoNoCurrent