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Dicloxacillin Sodium

Dicloxacillin Sodium Capsules, USP250 mg and 500 mg

Approved
Approval ID

5e878949-ae82-41e9-9fc6-3c54fe28c032

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-0937
Application NumberANDA061454
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicloxacillin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2012
FDA Product Classification

INGREDIENTS (5)

GELATINInactive
Code: 2G86QN327L
Classification: IACT
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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Dicloxacillin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-1380
Application NumberANDA061454
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicloxacillin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2012
FDA Product Classification

INGREDIENTS (5)

DICLOXACILLIN SODIUMActive
Quantity: 500 mg in 1 1
Code: 4HZT2V9KX0
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Dicloxacillin Sodium - FDA Drug Approval Details