MedPath

Altabax

Approved
Approval ID

9fae06b5-bbd5-400a-a7a6-3a4e238361f8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 13, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

retapamulin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6096
Application NumberNDA022055
Product Classification
M
Marketing Category
C73594
G
Generic Name
retapamulin
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 13, 2010
FDA Product Classification

INGREDIENTS (2)

RETAPAMULINActive
Quantity: 10 mg in 1 g
Code: 4MG6O8991R
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

Drug Labeling Information

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 1/13/2010

4 CONTRAINDICATIONS

None.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/13/2010

FULL PRESCRIBING INFORMATION

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