Home NDC 84720-532 quitine nicotine
Product NDC 84720-532
11-digit product format 847200532
Labeler code 84720
Product ID 84720-532_9941d3e7-1008-4854-a6e8-605dfc210493
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler QUITINE LLC
Application ANDA076779
Marketing category ANDA
Marketing start 2024-12-04
Substance NICOTINE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A076779-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16
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 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076779-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2004-09-16 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base quitine 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 84720-532-70 quitine nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 3 84720-532-70 quitine nicotine 240 in 1 CARTON GUM, CHEWING 240 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84720-532 QUITINE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUITINE LLC] 2 Current NDC, 2 package rows 20241215_302f4785-77e6-433f-83d9-d0d2618d5ef2.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 · 12 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84720-532-70 84720053270 240 BLISTER PACK in 1 CARTON (84720-532-70) / 1 GUM, CHEWING in 1 BLISTER PACK 240 blister pack 2024-12-04 No No Current