Sterile Water

Product NDC
52584-147
11-digit product format
525840147
Labeler code
52584
Product ID
52584-147_ccbb8a02-7d4f-4b97-a2bc-4790da082a2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sterile Water
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA206369
Marketing category
ANDA
Marketing start
2019-06-19
Marketing end
0000-00-00
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-147-012022-01-28C16284748780-1d6a99b39-6ac3-a426-e053-dadaa90af4c2Sterile Water

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-147-01Sterile Water10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
52584-147-01Sterile Water1 in 1 BAGINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-147STERILE WATER INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]1Legacy NDC, 2 package rows20190704_c164c6cd-c93d-4fa6-a06f-a62732f3a727.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-147-01525840147011 VIAL, SINGLE-DOSE in 1 BAG (52584-147-01) > 10 mL in 1 VIAL, SINGLE-DOSE2019-06-190000-00-00NoNoCurrent