MedPath
FDA Approval

Permethrin

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

FDA Approval Summary

Effective Date
April 26, 2018
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.

Travis County Healthcare District

Central Texas Community Health Centers

797039398

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
76413-159
Application Number
ANDA074806
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
March 1, 2018
Code: 509F88P9SZClass: ACTIBQuantity: 50 mg in 1 g
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
COCONUT OILInactive
Code: Q9L0O73W7LClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HEClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
CETETH-10Inactive
Code: LF9X1PN3XJClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CETETH-20Inactive
Code: I835H2IHHXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FORMALDEHYDEInactive
Code: 1HG84L3525Class: IACT
© Copyright 2025. All Rights Reserved by MedPath
Permethrin - FDA Approval | MedPath