Home NDC 11673-411-78 up and up nicotine
Product NDC 11673-411
Requested package NDC 11673-411-78
11-digit product format 116730411
Labeler code 11673
Product ID 11673-411_9d5a6785-f69e-44cb-ac46-963116a3df79
Type HUMAN OTC DRUG
Nonproprietary name Nicotine polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Target Corporation
Application ANDA206394
Marketing category ANDA
Marketing start 2017-08-30
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 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 A206394-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG 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 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 cb3db0bc1861…
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11673-411 UP AND UP NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TARGET CORPORATION] 4 Legacy NDC 20210331_580b1def-25cc-4bdd-b80e-e2035b004808.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 · 41 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 11673-411-78 11673041178 100 BLISTER PACK in 1 CARTON (11673-411-78) > 1 GUM, CHEWING in 1 BLISTER PACK 100 blister pack 2017-08-31 0000-00-00 No No Current