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Ivermectin

Ivermectin Tablets USP, 3mg(IVERMECTIN)

Approved
Approval ID

23bb1ccf-1a35-438d-a0df-3ecc4fa30033

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 16, 2018

Manufacturers
FDA

Central Texas Community Health Centers

DUNS: 079674019

Products 1

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

Ivermectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76413-155
Application NumberANDA204154
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ivermectin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 9, 2017
FDA Product Classification

INGREDIENTS (6)

IVERMECTINActive
Quantity: 3 mg in 1 1
Code: 8883YP2R6D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Ivermectin - FDA Drug Approval Details