Home NDC 63443-5057 Nicotine Polacrilex Gum
Product NDC 63443-5057
11-digit product format 634435057
Labeler code 63443
Product ID 63443-5057_4b1e2904-b22d-4cb9-e063-6294a90a532c
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler Fertin Pharma A/S
Application ANDA214354
Marketing category ANDA
Marketing start 2022-12-21
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 A214354-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21
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.
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 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214354-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2022-12-21 a50c72e98297…
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 Polacrilex Gum
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 63443-5057-1 Nicotine Polacrilex Gum 10 in 1 CARTON GUM, CHEWING 10 3 63443-5057-1 Nicotine Polacrilex Gum 10 in 1 BLISTER PACK GUM, CHEWING 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63443-5057 NICOTINE POLACRILEX GUM (NICOTINE POLACRILEX) GUM, CHEWING [FERTIN PHARMA A/S] 1 Current NDC, Legacy NDC, 2 package rows 20230106_f1774540-7c2f-c60b-e053-2995a90a1ccb.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 · 1 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 63443-5057-1 63443505701 10 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACK 10 blister pack 2022-12-21 0000-00-00 No No Current