DICLOXACILLIN SODIUM
Dicloxacillin Sodium Capsules USP Rx only
Approved
Approval ID
9074b5a6-850c-4144-9097-bb21073ee54d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DICLOXACILLIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-565
Application NumberANDA216845
Product Classification
M
Marketing Category
C73584
G
Generic Name
DICLOXACILLIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (9)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DICLOXACILLIN SODIUMActive
Quantity: 250 mg in 1 1
Code: 4HZT2V9KX0
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DICLOXACILLIN SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-566
Application NumberANDA216845
Product Classification
M
Marketing Category
C73584
G
Generic Name
DICLOXACILLIN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (9)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
DICLOXACILLIN SODIUMActive
Quantity: 500 mg in 1 1
Code: 4HZT2V9KX0
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT