Home NDC 50090-3560 Rugby Nicotine Polacrilex Gum, Mint Flavor
Product NDC 50090-3560
11-digit product format 500903560
Labeler code 50090
Product ID 50090-3560_8daba42e-328d-4a3a-a233-0b457e7aa7f7
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler A-S Medication Solutions
Application ANDA076569
Marketing category ANDA
Marketing start 2004-07-29
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076569-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29
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 · 42 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 2026-08-18 06:07:40 2026-07 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076569-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-07-29 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Rugby Nicotine Polacrilex Gum, Mint Flavor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 2 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 314119 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3560-0 Rugby Nicotine Polacrilex Gum, Mint Flavor 11 in 1 CARTON GUM, CHEWING 11 16 50090-3560-0 Rugby Nicotine Polacrilex Gum, Mint Flavor 10 in 1 BLISTER PACK GUM, CHEWING 10 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3560 RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [A-S MEDICATION SOLUTIONS] 14 Current NDC, Legacy NDC, 2 package rows 20240511_7b70162e-0087-466f-9b8b-8289b6e90e39.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 · 5 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 50090-3560-0 50090356000 11 BLISTER PACK in 1 CARTON (50090-3560-0) / 10 GUM, CHEWING in 1 BLISTER PACK 11 blister pack 2018-08-29 0000-00-00 No No Current