Gentamicin Sulfate

Product NDC
0168-0071
11-digit product format
001680071
Labeler code
0168
Product ID
0168-0071_d9702c76-5f4e-4a76-b3a4-e7635f39d504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gentamicin sulfate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.
Application
ANDA062531
Marketing category
ANDA
Marketing start
1984-07-05
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
1 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8GENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
PROPYLENE GLYCOL MONOPALMITOSTEARATEINACTIVE INGREDIENTF76354LMGRGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE CREAM [DISPENSING SOLUTIONS, INC.]3
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8GENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
PROPYLENE GLYCOL MONOSTEARATEINACTIVE INGREDIENTF76354LMGRGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE CREAM [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197735gentamicin sulfate 0.1 % Topical CreamPSNe673c84f-d3cc-4e61-bdc7-5679cde9f3593
197735gentamicin 1 MG/ML Topical CreamSCDe673c84f-d3cc-4e61-bdc7-5679cde9f3593
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSYe673c84f-d3cc-4e61-bdc7-5679cde9f3593
197735gentamicin sulfate 0.1 % Topical CreamPSNe2eed774-9a41-4a03-b8c0-e785fabf32281
197735gentamicin 1 MG/ML Topical CreamSCDe2eed774-9a41-4a03-b8c0-e785fabf32281
197735gentamicin (as gentamicin sulfate) 0.1 % Topical CreamSYe2eed774-9a41-4a03-b8c0-e785fabf32281