Dicloxacillin Sodium
Dicloxacillin Sodium Capsules USP Rx only
Approved
Approval ID
a4174fda-68f7-4834-be58-dd6b167cf9f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2020
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
Products 1
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 Code76420-183
Application NumberANDA062286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicloxacillin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2020
FDA Product Classification
INGREDIENTS (13)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DICLOXACILLIN SODIUMActive
Quantity: 500 mg in 1 1
Code: 4HZT2V9KX0
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITAN MONOLAURATEInactive
Code: 6W9PS8B71J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT