Home NDC 60290-077 VARENICLINE
Product NDC 60290-077
11-digit product format 602900077
Labeler code 60290
Product ID 60290-077_5bf974b2-49dd-528f-e063-6394a90abaca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VARENICLINE
Dosage form TABLET
Route ORAL
Labeler Umedica Laboratories USA Inc.
Application ANDA218985
Marketing category ANDA
Marketing start 2026-01-09
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218985-001 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2026-01-09 A218985-002 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2026-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A218985-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2026-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218985-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2026-01-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218985-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2026-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218985-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2026-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218985-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2026-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218985-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2026-01-09 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218985-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2026-01-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218985-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2026-01-09 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base VARENICLINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARENICLINE TARTRATE .5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60290-077-01 VARENICLINE 56 in 1 BOTTLE TABLET 56 2 60290-077-02 VARENICLINE 60 in 1 CARTON TABLET 60 2 60290-077-02 VARENICLINE 1 in 1 BLISTER PACK TABLET 1 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60290-077-01 60290007701 56 TABLET in 1 BOTTLE (60290-077-01) 56 tablet 2026-01-09 No No Current 60290-077-02 60290007702 60 BLISTER PACK in 1 CARTON (60290-077-02) / 1 TABLET in 1 BLISTER PACK 60 blister pack 2026-01-09 No No Current