Home NDC 63868-848 Nicotine
Product NDC 63868-848
11-digit product format 638680848
Labeler code 63868
Product ID 63868-848_ca1001ad-f698-4ba0-9b1b-63ef3cb1a9d9
Type HUMAN OTC DRUG
Nonproprietary name nicotine polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application ANDA074707
Marketing category ANDA
Marketing start 2020-12-31
Marketing end 0000-00-00
Substance NICOTINE
Active strength 4 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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…
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-848 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 3 Legacy NDC 20230509_11b23262-676e-44fb-a853-43c1a64d57eb.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-848-11 63868084811 110 BLISTER PACK in 1 CARTON (63868-848-11) > 1 GUM, CHEWING in 1 BLISTER PACK 110 blister pack 2020-12-31 0000-00-00 No No Current