Home NDC 60290-095 varenicline
Product NDC 60290-095
11-digit product format 602900095
Labeler code 60290
Product ID 60290-095_5bf974b2-49dd-528f-e063-6394a90abaca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name varenicline
Dosage form KIT
Labeler Umedica Laboratories USA Inc.
Application ANDA218985
Marketing category ANDA
Marketing start 2026-01-09
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 DailyMed Product Concepts# DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60290-095-01 60290009501 1 KIT in 1 BLISTER PACK (60290-095-01) * 11 TABLET in 1 BLISTER PACK * 42 TABLET in 1 BLISTER PACK 1 kit 2026-04-17 No No Current