Home NDC 17856-3030-1 Rugby Nicotine Polacrilex Gum, Original Flavor
Product NDC 17856-3030
Requested package NDC 17856-3030-1
11-digit product format 178563030
Labeler code 17856
Product ID 17856-3030_3892fb10-9ea9-9058-e063-6294a90a26b8
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA074707
Marketing category ANDA
Marketing start 2018-06-05
Substance NICOTINE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-3030 17856-3030-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-3030 17856-3030-1 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-3030 17856-3030-1 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 A074707-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19
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 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074707-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 1999-03-19 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Rugby Nicotine Polacrilex Gum, Original Flavor
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-3030-1 Rugby Nicotine Polacrilex Gum, Original Flavor 50 in 1 CASE GUM, CHEWING 50 5 17856-3030-2 Rugby Nicotine Polacrilex Gum, Original Flavor 1 in 1 POUCH GUM, CHEWING 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-3030 RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [ATLANTIC BIOLOGICALS CORP.] 4 Current NDC, Legacy NDC, 2 package rows 20240417_57e08517-4c8a-487a-bfbe-2a43f105f4b9.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 · 11 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 17856-3030-1 17856303001 50 POUCH in 1 CASE (17856-3030-1) / 1 GUM, CHEWING in 1 POUCH (17856-3030-2) 50 pouch 2024-04-17 0000-00-00 No No Current