NDC 52584-079

STERILE WATER

Water

STERILE WATER is a Intramuscular; Intravenous; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Water.

Product ID52584-079_3e60754b-7866-4d5d-80e6-86efec6e3f1c
NDC52584-079
Product TypeHuman Prescription Drug
Proprietary NameSTERILE WATER
Generic NameWater
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-07-03
Marketing CategoryNDA / NDA
Application NumberNDA018801
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameWATER
Active Ingredient Strength1 mL/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52584-079-25

1 VIAL, GLASS in 1 BAG (52584-079-25) > 100 mL in 1 VIAL, GLASS
Marketing Start Date2018-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-079-25 [52584007925]

STERILE WATER INJECTION
Marketing CategoryNDA
Application NumberNDA018801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-03

Drug Details

Active Ingredients

IngredientStrength
WATER1 mL/mL

OpenFDA Data

SPL SET ID:a82d2dd5-dd65-4208-ab85-f0680d0e2bf6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 540930
  • NDC Crossover Matching brand name "STERILE WATER" or generic name "Water"

    NDCBrand NameGeneric Name
    0264-2101Sterile WaterWater
    0264-7385Sterile WaterWater
    0264-7386Sterile WaterSterile Water
    0264-7850Sterile WaterWater
    0338-0003Sterile WaterWater
    0338-0004Sterile WaterWater
    0338-0013Sterile WaterWater
    0409-4887Sterile WaterSterile Water
    0409-6139Sterile WaterSterile Water
    0409-7118Sterile WaterSterile Water
    0409-7139Sterile WaterSterile Water
    0409-7973Sterile WaterSterile Water
    0409-7990Sterile WaterSterile Water
    0517-3005Sterile WaterSterile Water
    0517-3020Sterile WaterSterile Water
    0517-3010Sterile WaterSterile Water
    71872-7041Sterile WaterSterile Water
    0641-6147Sterile WaterSterile Water
    50090-2874Sterile WaterSterile Water
    50242-001Sterile WaterSterile Water
    51662-1329STERILE WATERSTERILE WATER
    51662-1265STERILE WATERSTERILE WATER
    51662-1266STERILE WATERSTERILE WATER
    52584-079STERILE WATERSTERILE WATER
    52584-887Sterile WaterSterile Water
    55154-0127Sterile WaterSterile Water
    55154-2379Sterile WaterSterile Water
    63323-178Sterile WaterSterile Water
    63323-185Sterile WaterSterile Water
    64725-4887Sterile WaterSterile Water
    0990-7118Sterile WaterSterile Water
    52584-147Sterile WaterSterile Water
    0990-7973Sterile WaterSterile Water
    0990-6139Sterile WaterSterile Water
    0990-7139Sterile WaterSterile Water
    0990-7990Sterile WaterSterile Water
    0173-0518Diluentwater
    0173-0857Diluentwater
    0404-7198EyewashWater
    0006-4309STERILE DILUENTSterile Water

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