Home NDC 33342-489 Varenicline
Product NDC 33342-489
11-digit product format 333420489
Labeler code 33342
Product ID 33342-489_c6a5644a-f80a-4e20-9850-aea0360a76fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Varenicline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA215048
Marketing category ANDA
Marketing start 2024-12-10
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215048-001 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 A215048-002 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09
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 2026-08-18 06:07:40 2026-07 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215048-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2024-12-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215048-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2024-12-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Varenicline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARENICLINE TARTRATE .5 mg/1
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-489-19 Varenicline 56 in 1 BOTTLE TABLET, FILM COATED 56 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-489 VARENICLINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20250521_c325d582-8f43-40ea-b348-87837de97a07.zip
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 Marketing start Sample Exclude flag Status 33342-489-19 33342048919 56 TABLET, FILM COATED in 1 BOTTLE (33342-489-19) 2024-12-10 No No Current