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Ivermectin

These highlights do not include all the information needed to use IVERMECTIN CREAM safely and effectively. See full prescribing information for IVERMECTIN CREAM. IVERMECTIN cream, 1%, for topical use Initial U.S. Approval: 1996

Approved
Approval ID

81193a2d-dc0a-4ce5-a5c1-6dfd3195c4bc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 30, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-8754
Application NumberANDA210019
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ivermectin
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 25, 2021
FDA Product Classification

INGREDIENTS (15)

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN TRISTEARATEInactive
Code: 6LUM696811
Classification: IACT
IVERMECTINActive
Quantity: 10 mg in 1 g
Code: 8883YP2R6D
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

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Ivermectin - FDA Drug Approval Details