Home NDC 50090-4481 CHANTIX
Product NDC 50090-4481
11-digit product format 500904481
Labeler code 50090
Product ID 50090-4481_c604c017-10cb-4d16-8de3-27494cdd70df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name varenicline tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA021928
Marketing category NDA
Marketing start 2006-05-10
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 · 30 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 50090-4481-0 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 50090-4481-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-4481-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-4481-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-4481-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-4481-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-4481-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-4481-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-4481-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-4481-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-4481-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-4481-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-4481-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-4481-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-4481-0 1332a3947898…d4bfe170f9cd…
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 N021928-001 CHANTIX VARENICLINE TARTRATE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 N021928-002 CHANTIX VARENICLINE TARTRATE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10
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.
Product history page 1 of 3 · 82 observed 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 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-001 CHANTIX EQ 0.5MG BASE TABLET / ORAL RLD 2006-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-002 CHANTIX EQ 1MG BASE TABLET / ORAL RLD 2006-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021928-001 CHANTIX EQ 0.5MG BASE TABLET / ORAL AB RLD 2006-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-002 CHANTIX EQ 1MG BASE TABLET / ORAL AB RLD 2006-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021928-001 CHANTIX EQ 0.5MG BASE TABLET / ORAL AB RLD 2006-05-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-002 CHANTIX EQ 1MG BASE TABLET / ORAL AB RLD 2006-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021928-001 CHANTIX EQ 0.5MG BASE TABLET / ORAL RLD 2006-05-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-002 CHANTIX EQ 1MG BASE TABLET / ORAL RLD, RS 2006-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021928-001 CHANTIX EQ 0.5MG BASE TABLET / ORAL AB RLD 2006-05-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021928-002 CHANTIX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2006-05-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021928-001 CHANTIX EQ 0.5MG BASE TABLET / ORAL AB RLD 2006-05-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021928-002 CHANTIX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2006-05-10 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 180 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-001 6890927 2022-05-06 U-56 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-001 7265119 2022-08-03 U-56 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-001 6890927*PED 2022-11-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-001 7265119*PED 2023-02-03 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-002 6890927 2022-05-06 U-56 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-002 7265119 2022-08-03 U-56 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-002 6890927*PED 2022-11-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021928-002 7265119*PED 2023-02-03 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021928-001 6890927 2022-05-06 U-56 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-001 7265119 2022-08-03 U-56 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-001 6890927*PED 2022-11-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-001 7265119*PED 2023-02-03 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-002 6890927 2022-05-06 U-56 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-002 7265119 2022-08-03 U-56 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-002 6890927*PED 2022-11-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021928-002 7265119*PED 2023-02-03 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021928-001 6890927 2022-05-06 U-56 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-001 7265119 2022-08-03 U-56 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-001 6890927*PED 2022-11-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-001 7265119*PED 2023-02-03 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-002 6890927 2022-05-06 U-56 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-002 7265119 2022-08-03 U-56 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-002 6890927*PED 2022-11-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021928-002 7265119*PED 2023-02-03 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021928-001 6410550 2020-05-10 U-56 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-001 6410550*PED 2020-11-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-001 6890927 2022-05-06 U-56 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-001 7265119 2022-08-03 U-56 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-001 6890927*PED 2022-11-06 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-001 7265119*PED 2023-02-03 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-002 6410550 2020-05-10 U-56 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-002 6410550*PED 2020-11-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-002 6890927 2022-05-06 U-56 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-002 7265119 2022-08-03 U-56 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-002 6890927*PED 2022-11-06 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021928-002 7265119*PED 2023-02-03 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021928-001 6890927 2022-05-06 U-56 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021928-001 7265119 2022-08-03 U-56 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021928-001 6890927*PED 2022-11-06 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021928-001 7265119*PED 2023-02-03 Pediatric extension bb7c543d1eb4…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 112 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4481-0 CHANTIX 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 50090-4481 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 3 Legacy NDC, 1 package rows 20210417_9a0d0273-8099-420a-b4e1-097153a4aecb.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-4481-0 50090448100 56 TABLET, FILM COATED in 1 BOTTLE (50090-4481-0) 2019-08-28 0000-00-00 No No Current