Home NDC 68196-365 members mark nicotine
Product NDC 68196-365
11-digit product format 681960365
Labeler code 68196
Product ID 68196-365_fceafb96-e070-4c3a-9f41-f3f749b2a030
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Sam's West Inc
Application ANDA091349
Marketing category ANDA
Marketing start 2020-06-30
Marketing end 0000-00-00
Substance NICOTINE
Active strength 2 mg/1
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 68196-365 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68196-365 68196-365-47 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091349-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20
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 2 · 41 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 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 cb3db0bc1861…
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68196-365 MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 3 Legacy NDC 20210422_3e107650-4d6c-41f2-9bed-2ffceca22e8b.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68196-365-47 68196036547 150 BLISTER PACK in 1 CARTON (68196-365-47) > 1 GUM, CHEWING in 1 BLISTER PACK 150 blister pack 2020-06-30 0000-00-00 No No Current