FDA.reportPublic FDA data

Gentamicin Sulfate

Product NDC
45802-056
11-digit product format
458020056
Labeler code
45802
Product ID
45802-056_11688357-e569-4785-a313-18115f24c5bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA062307
Marketing category
ANDA
Marketing start
2006-08-23
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
Rxcui197735

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-056-11Gentamicin Sulfate30 g in 1 TUBECREAM3013
45802-056-11Gentamicin Sulfate1 in 1 CARTONCREAM113
45802-056-35Gentamicin Sulfate1 in 1 CARTONCREAM113
45802-056-35Gentamicin Sulfate15 g in 1 TUBECREAM1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-056-11GM - Gram45802-05663bbae86-a2c8-4c87-97c8-4e095a9de49212012-07-24
45802-056-35GM - Gram45802-0563629159e-c462-454d-aa64-f1d2ea2fa3c312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8GENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
PROPYLENE GLYCOL MONOPALMITOSTEARATEINACTIVE INGREDIENTF76354LMGRGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
SORBITOLINACTIVE INGREDIENT506T60A25RGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE CREAM [PERRIGO NEW YORK INC]5
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8GENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOL MONOSTEARATEINACTIVE INGREDIENTF76354LMGRGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-056GENTAMICIN SULFATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 4 package rows20250221_4cfbe37e-11d6-46fc-b287-0561387b17b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197735gentamicin sulfate 0.1 % Topical CreamPSN4cfbe37e-11d6-46fc-b287-0561387b17b713
197735gentamicin 1 MG/ML Topical CreamSCD4cfbe37e-11d6-46fc-b287-0561387b17b713
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSY4cfbe37e-11d6-46fc-b287-0561387b17b713
197735gentamicin sulfate 0.1 % Topical CreamPSN210dde2f-6ea0-4068-8f6c-b9d62c67d12a1
197735gentamicin 1 MG/ML Topical CreamSCD210dde2f-6ea0-4068-8f6c-b9d62c67d12a1
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSY210dde2f-6ea0-4068-8f6c-b9d62c67d12a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-056-11458020056111 TUBE in 1 CARTON (45802-056-11) / 30 g in 1 TUBE1 tube2006-08-230000-00-00NoNoCurrent
45802-056-35458020056351 TUBE in 1 CARTON (45802-056-35) / 15 g in 1 TUBE1 tube2006-12-050000-00-00NoNoCurrent