Home NDC 71205-381 CHANTIX
Product NDC 71205-381
11-digit product format 712050381
Labeler code 71205
Product ID 71205-381_f22e3aef-714b-4014-8d77-83ee03fd1f57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name varenicline tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application NDA021928
Marketing category NDA
Marketing start 2006-05-10
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 2026-12-31
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 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CHANTIX VARENICLINE TARTRATE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 N021928-002 CHANTIX VARENICLINE TARTRATE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10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UTC 2026-02 N021928-001 CHANTIX EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021928-002 CHANTIX EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD 2006-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021928-001 CHANTIX EQ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.
Additional Listing Data#
Finished product Yes
Brand name base CHANTIX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARENICLINE TARTRATE 1 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 636676 Internal RxNorm lookup 637190 Internal RxNorm lookup 749788 Internal RxNorm lookup 795735 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 71205-381-56 CHANTIX 1 in 1 CARTON TABLET, FILM COATED 1 1 71205-381-56 CHANTIX 56 in 1 BLISTER PACK TABLET, FILM COATED 56 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-381 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [PROFICIENT RX LP] 1 Current NDC, Legacy NDC, 2 package rows 20200121_f22e3aef-714b-4014-8d77-83ee03fd1f57.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 Units Marketing start Marketing end Sample Exclude flag Status 71205-381-56 71205038156 1 BLISTER PACK in 1 CARTON (71205-381-56) / 56 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2020-01-09 0000-00-00 No No Current