Home NDC 60290-095-01 varenicline
Product NDC 60290-095
Requested package NDC 60290-095-01
11-digit product format 602900095
Labeler code 60290
Product ID 60290-095_54d2990d-e5aa-373e-e063-6294a90a4a98
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
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 2026-02-19 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# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218985-001 AB 1 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218985-002 AB 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218985-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218985-002 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base varenicline
Listing expiration 2027-12-31 Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 82269ASB48 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 636671 Internal RxNorm lookup 636676 Internal RxNorm lookup 749289 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample 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 0 Current