Home Applications 016682 Application 016682
Type NDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016682-001 LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N016682-001 AP
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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N016682-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N016682-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016682-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016682-001 LACTATED RINGER'S IN PLASTIC CONTAINER 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lactated Ringers SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE Baxter Healthcare Company dad7735c-709b-40ea-ab7a-15577e24a966 2025-10-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 016682 application number: NDA016682 ndc (product): 0338-0117
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-0117 Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride Baxter Healthcare Corporation NDA Current 0338-0117 Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride Baxter Healthcare Corporation NDA Current 0338-0117 Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride Baxter Healthcare Corporation NDA Current 0338-0117 Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride Baxter Healthcare Corporation NDA Current 0338-0117 Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride Baxter Healthcare Corporation NDA Current 70529-025 Lacellate Solution - 250 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-025 Lacellate Solution - 250 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-025 Lacellate Solution - 250 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-026 Lacellate Solution - 500 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-026 Lacellate Solution - 500 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-026 Lacellate Solution - 500 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-027 Lacellate Solution - 1000 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-027 Lacellate Solution - 1000 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current 70529-027 Lacellate Solution - 1000 Sodium chloride, potassium chloride, sodium lactate and calcium chloride IT3 Medical LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84116 SUPPL 2025-11-06 84076 SUPPL 2025-11-06 79225 SUPPL 2024-07-29 79213 SUPPL 2024-07-25 60526 SUPPL 2020-01-23 60514 SUPPL 2019-10-10 33190 SUPPL 2011-11-04 13019 SUPPL 2011-10-24 13018 SUPPL 2003-07-06 479 SUPPL 2002-08-01 13017 SUPPL 2002-04-03