Home NDC 68391-309-76 Berkley and Jensen Nicotine
Product NDC 68391-309
Requested package NDC 68391-309-76
11-digit product format 683910309
Labeler code 68391
Product ID 68391-309_ecc73ee8-3d06-4daf-b93b-4d180cc6bc68
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler BJWC
Application ANDA206393
Marketing category ANDA
Marketing start 2017-02-28
Substance NICOTINE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 1 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 package package 68391-309 68391-309-76 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 A206393-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15
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 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Berkley and Jensen Nicotine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311975 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 68391-309-25 Berkley and Jensen Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 7 68391-309-25 Berkley and Jensen Nicotine 110 in 1 CARTON GUM, CHEWING 110 7 68391-309-29 Berkley and Jensen Nicotine 2 in 1 CARTON GUM, CHEWING 2 7 68391-309-29 Berkley and Jensen Nicotine 110 in 1 CARTON GUM, CHEWING 110 7 68391-309-70 Berkley and Jensen Nicotine 120 in 1 CARTON GUM, CHEWING 120 7 68391-309-70 Berkley and Jensen Nicotine 2 in 1 CARTON GUM, CHEWING 2 7 68391-309-76 Berkley and Jensen Nicotine 120 in 1 CARTON GUM, CHEWING 120 7 68391-309-76 Berkley and Jensen Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-309 BERKLEY AND JENSEN NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [BJWC] 6 Current NDC, Legacy NDC, 8 package rows 20250315_b04f4f1e-55d3-4486-acf1-6a93dc919f2d.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 3 · 46 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 68391-309-76 68391030976 120 BLISTER PACK in 1 CARTON (68391-309-76) > 1 GUM, CHEWING in 1 BLISTER PACK 120 blister pack 2020-12-11 0000-00-00 No No Current