Home NDC 45802-206-25 Nicotine Polacrilex
Product NDC 45802-206
Requested package NDC 45802-206-25
11-digit product format 458020206
Labeler code 45802
Product ID 45802-206_c30d1ba1-275a-4b36-be40-bcdec3fd73ba
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Perrigo New York Inc
Application ANDA078325
Marketing category ANDA
Marketing start 2014-04-09
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 A078325-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30
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 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 cb3db0bc1861…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 NICOTINE ACTIVE MOIETY 6M3C89ZY6R NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U NICOTINE POLACRILEX GUM, CHEWING [PERRIGO NEW YORK INC] 2
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 45802-206-25 45802020625 110 BLISTER PACK in 1 CARTON (45802-206-25) > 1 GUM, CHEWING in 1 BLISTER PACK 110 blister pack 2014-04-09 0000-00-00 No No Current