NDC 52584-887

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 & Vaccines, Inc. The primary component is Water.

Product ID52584-887_1983177f-9d92-463b-bb0e-068682a710aa
NDC52584-887
Product TypeHuman Prescription Drug
Proprietary NameSterile Water
Generic NameWater
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2010-03-01
Marketing CategoryNDA / NDA
Application NumberNDA018801
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameWATER
Active Ingredient Strength1 mL/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52584-887-10

1 VIAL, SINGLE-DOSE in 1 BAG (52584-887-10) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2016-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-887-50 [52584088750]

Sterile Water INJECTION
Marketing CategoryNDA
Application NumberNDA018801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-20
Marketing End Date2021-07-01

NDC 52584-887-99 [52584088799]

Sterile Water INJECTION
Marketing CategoryNDA
Application NumberNDA018801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-20
Marketing End Date2017-01-18

NDC 52584-887-20 [52584088720]

Sterile Water INJECTION
Marketing CategoryNDA
Application NumberNDA018801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-20
Marketing End Date2021-07-01

NDC 52584-887-10 [52584088710]

Sterile Water INJECTION
Marketing CategoryNDA
Application NumberNDA018801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-20
Marketing End Date2021-07-01

Drug Details

Active Ingredients

IngredientStrength
WATER1 mL/mL

OpenFDA Data

SPL SET ID:c6eed2ad-25f3-479e-9c28-1945eea88f8d
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

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