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Dicloxacillin Sodium

Dicloxacillin Sodium Capsules, USP250 mg and 500 mg

Approved
Approval ID

4e2a0cc3-009b-40d0-a0e9-43feb7b250a2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 23, 2013

Manufacturers
FDA

Liberty Pharmaceuticals, Inc.

DUNS: 012568840

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 Code0440-1380
Application NumberANDA061454
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicloxacillin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2013
FDA Product Classification

INGREDIENTS (5)

DICLOXACILLIN SODIUMActive
Quantity: 250 mg in 1 1
Code: 4HZT2V9KX0
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Dicloxacillin Sodium - FDA Drug Approval Details