VARENICLINE

Product NDC

60505-4794

11-digit product format

605054794

Labeler code

60505

Product ID

60505-4794_82c3cf49-a3f0-4566-3049-6f52d8d08a74

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

VARENICLINE

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Apotex Corp

Application

ANDA201962

Marketing category

ANDA

Marketing start

2023-01-30

Substance

VARENICLINE TARTRATE

Active strength

.5 mg/1

Pharmacologic classes

Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]

NDC exclude flag

No

Listing certified through

2027-12-31

Current FDA listing

Yes