NDC 51662-1301

0.9% SODIUM CHLORIDE

0.9% Sodium Chloride

0.9% SODIUM CHLORIDE is a Irrigation Irrigant in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Sodium Chloride.

Product ID51662-1301_78825011-268d-784b-e053-2991aa0ae0d4
NDC51662-1301
Product TypeHuman Prescription Drug
Proprietary Name0.9% SODIUM CHLORIDE
Generic Name0.9% Sodium Chloride
Dosage FormIrrigant
Route of AdministrationIRRIGATION
Marketing Start Date2018-10-18
Marketing CategoryNDA / NDA
Application NumberNDA017514
Labeler NameHF Acquisition Co LLC, DBA HealthFirst
Substance NameSODIUM CHLORIDE
Active Ingredient Strength900 mg/100mL
Pharm ClassesOsmotic 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 51662-1301-1

1000 mL in 1 BOTTLE, PLASTIC (51662-1301-1)
Marketing Start Date2018-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1301-1 [51662130101]

0.9% SODIUM CHLORIDE IRRIGANT
Marketing CategoryNDA
Application NumberNDA017514
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-18
Inactivation Date2020-01-31
Reactivation Date2020-02-07

Drug Details

Active Ingredients

IngredientStrength
SODIUM CHLORIDE900 mg/100mL

OpenFDA Data

SPL SET ID:78825011-268c-784b-e053-2991aa0ae0d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486515
  • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]

    NDC Crossover Matching brand name "0.9% SODIUM CHLORIDE" or generic name "0.9% Sodium Chloride"

    NDCBrand NameGeneric Name
    51662-12600.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE
    51662-13010.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE
    51662-13080.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE
    51662-13590.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE
    51662-15170.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE
    51662-15180.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE
    51662-15200.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE
    51662-15770.9% SODIUM CHLORIDESODIUM CHLORIDE
    51662-16090.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDE

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