Gentamicin Sulfate

Product NDC
52584-207
11-digit product format
525840207
Labeler code
52584
Product ID
52584-207_7aa7e2df-5710-446d-b020-68cfe290edcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
ANDA062420
Marketing category
ANDA
Marketing start
2010-08-01
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
40 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-207-03525840207031 VIAL, SINGLE-DOSE in 1 BAG (52584-207-03) > 2 mL in 1 VIAL, SINGLE-DOSE2016-09-080000-00-00NoNoCurrent