Home NDC 59726-913-16 Nicotine
Product NDC 59726-913
Requested package NDC 59726-913-16
11-digit product format 597260913
Labeler code 59726
Product ID 59726-913_ecd9cb80-d22d-4582-bf97-cb227fef1d55
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler P & L Development, LLC
Application ANDA079038
Marketing category ANDA
Marketing start 2024-03-01
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 43 .
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 A079038-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08
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 · 43 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 2026-09-14 22:38:34 2026-08 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base 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 59726-913-16 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 4 59726-913-16 Nicotine 160 in 1 CARTON GUM, CHEWING 160 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59726-913 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [P & L DEVELOPMENT, LLC] 2 Current NDC, 2 package rows 20240710_fbb3f6af-529f-40d8-a193-1aed4f2aa769.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 · 10 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 59726-913-16 59726091316 160 BLISTER PACK in 1 CARTON (59726-913-16) / 1 GUM, CHEWING in 1 BLISTER PACK 160 blister pack 2024-03-01 No No Current