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Altabax

Approved
Approval ID

5da8f60f-c809-4161-a802-6fe823d532bb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 2, 2010

Manufacturers
FDA

Rebel Distributors Corp.

DUNS: 118802834

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 Code21695-644
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

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Altabax - FDA Drug Approval Details