Gentamicin Sulfate

Product NDC
53002-9291
11-digit product format
530029291
Labeler code
53002
Product ID
53002-9291_46507b73-1131-479b-9a42-13bd2aece374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA062196
Marketing category
ANDA
Marketing start
1996-04-05
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-9291-12023-06-07C16284748780-1f386c649-cbaa-0266-e053-dadaa90a7c1ade9b178a-b390-48e1-885e-84679a98f7df
53002-9291-12023-01-30C16284748780-1f386c649-cbaa-0266-e053-dadaa90a7c1ade9b178a-b390-48e1-885e-84679a98f7df

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9291-1530029291015 mL in 1 BOTTLE, DROPPER (53002-9291-1) 5 ml2019-01-010000-00-00NoNoCurrent