Dicloxacillin Sodium
Dicloxacillin Sodium Capsules USP Rx only
Approved
Approval ID
8478f242-c715-4984-ac1d-dc79dc28665e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-3125
Application NumberANDA062286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicloxacillin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2022
FDA Product Classification
INGREDIENTS (15)
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
DICLOXACILLIN SODIUMActive
Quantity: 500 mg in 1 1
Code: 4HZT2V9KX0
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Dicloxacillin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-3123
Application NumberANDA062286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicloxacillin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2022
FDA Product Classification
INGREDIENTS (15)
DICLOXACILLIN SODIUMActive
Quantity: 250 mg in 1 1
Code: 4HZT2V9KX0
Classification: ACTIM
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT