FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
45802-046
11-digit product format
458020046
Labeler code
45802
Product ID
45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA062351
Marketing category
ANDA
Marketing start
2006-07-10
Substance
GENTAMICIN SULFATE
Active strength
1 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gentamicin Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTAMICIN SULFATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8X7386QRLV
Rxcui310465

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-046-11Gentamicin Sulfate1 in 1 CARTONOINTMENT110
45802-046-11Gentamicin Sulfate30 g in 1 TUBEOINTMENT3010
45802-046-35Gentamicin Sulfate1 in 1 CARTONOINTMENT110
45802-046-35Gentamicin Sulfate15 g in 1 TUBEOINTMENT1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-046-11GM - Gram45802-046aa98e5f9-2997-4a40-bbee-3729b884ccc912012-07-24
45802-046-35GM - Gram45802-0469ac64330-b8f8-4062-b89f-8f42bb5c464e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE OINTMENT [PERRIGO NEW YORK INC]5
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE OINTMENT [PERRIGO NEW YORK INC]5
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPGENTAMICIN SULFATE OINTMENT [PERRIGO NEW YORK INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE OINTMENT [PERRIGO NEW YORK INC]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UGENTAMICIN SULFATE OINTMENT [PERRIGO NEW YORK INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN SULFATE OINTMENT [PERRIGO NEW YORK INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-046GENTAMICIN SULFATE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]10Current NDC, Legacy NDC, 4 package rows20250125_a9486ae1-350b-41c5-ae0c-a4d692bb2dfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310465gentamicin sulfate 0.1 % Topical OintmentPSNa9486ae1-350b-41c5-ae0c-a4d692bb2dfd10
310465gentamicin 0.001 MG/MG Topical OintmentSCDa9486ae1-350b-41c5-ae0c-a4d692bb2dfd10
310465gentamicin (as gentamicin sulfate) 0.1 % Topical OintmentSYa9486ae1-350b-41c5-ae0c-a4d692bb2dfd10
310465gentamicin sulfate 0.001 MG/MG Topical OintmentSYa9486ae1-350b-41c5-ae0c-a4d692bb2dfd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-046-11458020046111 TUBE in 1 CARTON (45802-046-11) / 30 g in 1 TUBE1 tube2006-08-280000-00-00NoNoCurrent
45802-046-35458020046351 TUBE in 1 CARTON (45802-046-35) / 15 g in 1 TUBE1 tube2006-07-100000-00-00NoNoCurrent