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FDA Approval

Permethrin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 10, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Permethrin(50 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Rebel Distributors Corp

Rebel Distributors Corp

118802834

Products1

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

Permethrin

Product Details

NDC Product Code
21695-907
Application Number
ANDA076369
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
January 5, 2007
Code: 509F88P9SZClass: ACTIBQuantity: 50 mg in 1 g
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CARBOMER 934Inactive
Code: Z135WT9208Class: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HEClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4Class: IACT
CETEARETH-25Inactive
Code: 8FA93U5T67Class: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
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