Home NDC 60505-4765 APO-VARENICLINE
Product NDC 60505-4765
11-digit product format 605054765
Labeler code 60505
Product ID 60505-4765_3bfed7dd-f8ff-fb1b-f712-7404ac18ca5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VARENICLINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start 2021-07-16
Marketing end 0000-00-00
Substance VARENICLINE TARTRATE
Active strength 1 mg/1
Pharmacologic classes Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60505-4765-5 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60505-4765-5 f5e01cc5f278…a2eaf40c39c3…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-4765-5 60505476505 56 TABLET, FILM COATED in 1 BOTTLE (60505-4765-5) 2021-07-16 0000-00-00 No No Current