Home NDC 75907-303-10 Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint
Product NDC 75907-303
Requested package NDC 75907-303-10
11-digit product format 759070303
Labeler code 75907
Product ID 75907-303_6dec3f9c-5e70-4992-aae4-822d470312a5
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA078697
Marketing category ANDA
Marketing start 2025-06-12
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 44 .
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 A078697-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29
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 · 44 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 2026-10-15 13:18:30 2026-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3a93d1ddd44b…
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 Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311975 Internal RxNorm lookup 2717264 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 75907-303-10 Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 10 in 1 BLISTER PACK GUM, CHEWING 10 10 75907-303-15 Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 10 in 1 BLISTER PACK GUM, CHEWING 10 10 75907-303-15 Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 15 in 1 CARTON GUM, CHEWING 15 10 75907-303-80 Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 8 in 1 CARTON GUM, CHEWING 8 10 75907-303-80 Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 10 in 1 BLISTER PACK GUM, CHEWING 10 10
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 · 13 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 75907-303-10 75907030310 10 GUM, CHEWING in 1 BLISTER PACK (75907-303-10) 2025-06-12 No No Current