Home NDC 68151-4953 CHANTIX
Product NDC 68151-4953
11-digit product format 681514953
Labeler code 68151
Product ID 68151-4953_88048960-8979-4063-8bbf-6000b8cf3c1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name varenicline tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Carilion Materials Management
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 E
Listing certified through 2018-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68151-4953-5 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68151-4953-5 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68151-4953-5 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68151-4953-5 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68151-4953-5 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68151-4953-5 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68151-4953-5 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68151-4953-5 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68151-4953-5 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68151-4953-5 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68151-4953-5 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68151-4953-5 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68151-4953-5 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68151-4953-5 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68151-4953-5 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68151-4953-5 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68151-4953-5 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68151-4953-5 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68151-4953-5 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68151-4953-5 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68151-4953-5 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68151-4953-5 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 68151-4953-5 CHANTIX 1 in 1 PACKAGE TABLET, FILM COATED 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VARENICLINE TARTRATE ACTIVE INGREDIENT 82269ASB48 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 VARENICLINE ACTIVE MOIETY W6HS99O8ZO CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68151-4953 CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 Legacy NDC, 1 package rows 20140820_4aa4019c-737f-4906-bfd9-ca37a74e7c40.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.
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DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68151-4953-5 68151495305 1 in 1 PACKAGE Historical