NDC 51662-1229

LACTATED RINGERS AND DEXTROSE

Sodium Lactate, Potassium Chloride, Calcium Chloride, Sodium Chloride, Dextrose

LACTATED RINGERS AND DEXTROSE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Sodium Lactate; Potassium Chloride; Calcium Chloride; Dextrose Monohydrate; Sodium Chloride.

Product ID51662-1229_7791f2c5-c49b-2f58-e053-2a91aa0a06cc
NDC51662-1229
Product TypeHuman Prescription Drug
Proprietary NameLACTATED RINGERS AND DEXTROSE
Generic NameSodium Lactate, Potassium Chloride, Calcium Chloride, Sodium Chloride, Dextrose
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-10-06
Marketing CategoryNDA / NDA
Application NumberNDA017608
Labeler NameHF Acquisition Co LLC, DBA HealthFirst
Substance NameSODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
Active Ingredient Strength310 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL
Pharm ClassesOsmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51662-1229-1

1 BAG in 1 POUCH (51662-1229-1) > 1000 mL in 1 BAG
Marketing Start Date2018-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1229-1 [51662122901]

LACTATED RINGERS AND DEXTROSE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017608
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-06
Inactivation Date2020-01-31
Reactivation Date2020-02-07

Drug Details

Active Ingredients

IngredientStrength
SODIUM LACTATE310 mg/100mL

OpenFDA Data

SPL SET ID:7791f2c5-c49a-2f58-e053-2a91aa0a06cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 847630
  • 847627
  • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Potassium Compounds [CS]
    • Potassium Salt [EPC]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Blood Coagulation Factor [EPC]
    • Increased Coagulation Factor Activity [PE]
    • Calcium [CS]
    • Cations
    • Divalent [CS]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]

    NDC Crossover Matching brand name "LACTATED RINGERS AND DEXTROSE" or generic name "Sodium Lactate, Potassium Chloride, Calcium Chloride, Sodium Chloride, Dextrose"

    NDCBrand NameGeneric Name
    0338-0125Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATE
    0409-7929Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE
    0990-7929Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE
    51662-1229LACTATED RINGERS AND DEXTROSESODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE
    51662-1521LACTATED RINGERS AND DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.