Sterile Water

Product NDC
65219-187
11-digit product format
652190187
Labeler code
65219
Product ID
65219-187_0a672bdf-163d-4af5-a791-f815de5b309c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WATER
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA088400
Marketing category
ANDA
Marketing start
2022-04-29
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
059QF0KO0RWATER7732-18-5WATER

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-187-106521901871025 VIAL, SINGLE-DOSE in 1 TRAY (65219-187-10) / 100 mL in 1 VIAL, SINGLE-DOSE (65219-187-01) 2022-04-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sterile Water for Injection, USPFresenius Kabi USA, LLC2022-06-22HUMAN PRESCRIPTION DRUG LABEL1