Home NDC 0363-0429 Nicotine
Product NDC 0363-0429
11-digit product format 003630429
Labeler code 0363
Product ID 0363-0429_48fa2d59-67fc-45a8-b55b-43043d4a41b7
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler Walgreen Company
Application ANDA078697
Marketing category ANDA
Marketing start 2016-11-30
Marketing end 2019-09-30
Substance NICOTINE
Active strength 4 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078697-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29
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 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 cb3db0bc1861…
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 · 14 matching rows.