NDC 43598-908 – Varenicline tartrate

Varenicline Tartrate 1 mg/1 · Tablet, Film Coated · Oral

Human Prescription Drug 1 recall

Product NDC43598-908

Product details

Brand name: Varenicline tartrate
Generic name: Varenicline tartrate
Labeler: Dr. Reddys Laboratories Inc.
Dosage form: Tablet, Film Coated
Route: Oral
Marketing category: ANDA · ANDA215931
Marketed since: December 13, 2024
Listing expires: December 31, 2026
Pharmacologic class: Cholinergic Receptor Agonist; Partial Cholinergic Nicotinic Agonist

Package NDC	Description	Since
43598-908-56	56 TABLET, FILM COATED in 1 BOTTLE (43598-908-56)	Dec 13, 2024

D-0219-2026 Dec 17, 2025 · Class III
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

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