Last Updated: April 30, 2026

Details for New Drug Application (NDA): 216863

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NDA 216863 describes IVERMECTIN, which is a drug marketed by Padagis Israel, Teva Pharms Usa, Zydus Lifesciences, Taro, E5 Pharma, Edenbridge Pharms, Epic Pharma Llc, Rubicon Research, and Senores Pharms, and is included in eleven NDAs. It is available from nineteen suppliers. Additional details are available on the IVERMECTIN profile page.

The generic ingredient in IVERMECTIN is ivermectin. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for 216863

Tradename:	IVERMECTIN
Applicant:	Zydus Lifesciences
Ingredient:	ivermectin
Patents:	0

Pharmacology for NDA: 216863

Medical Subject Heading (MeSH) Categories for 216863

Antiparasitic Agents
Insecticides

Suppliers and Packaging for NDA: 216863

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVERMECTIN	ivermectin	TABLET;ORAL	216863	ANDA	Zydus Lifesciences Limited	70771-1731	70771-1731-3	2 BLISTER PACK in 1 CARTON (70771-1731-3) / 10 TABLET in 1 BLISTER PACK (70771-1731-2)
IVERMECTIN	ivermectin	TABLET;ORAL	216863	ANDA	Viona Pharmaceuticals Inc	72578-223	72578-223-83	2 BLISTER PACK in 1 CARTON (72578-223-83) / 10 TABLET in 1 BLISTER PACK (72578-223-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Feb 26, 2026	TE:	AB	RLD:	No

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