MedPath

STROMECTOL

STROMECTOL® (IVERMECTIN) TABLETS

Approved
Approval ID

5d140f06-e46b-4cdd-97e4-37b6cf4ade13

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 11, 2016

Manufacturers
FDA

Department of State Health Services, Pharmacy Branch

DUNS: 781992540

Products 1

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

ivermectin

PRODUCT DETAILS

NDC Product Code55695-019
Application NumberNDA050742
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 11, 2016
Generic Nameivermectin

INGREDIENTS (6)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
IVERMECTINActive
Quantity: 3 mg in 1 1
Code: 8883YP2R6D
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

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