Home NDC 43598-484 Nicotine Polacrilex
Product NDC 43598-484
11-digit product format 435980484
Labeler code 43598
Product ID 43598-484_1ae4bead-7050-e5ac-74ee-bcb145e68af8
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form LOZENGE
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA212983
Marketing category ANDA
Marketing start 2020-09-11
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 43598-484 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 43598-484 43598-484-99 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 43598-484-99 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 43598-484-99 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 43598-484-99 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 43598-484-99 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 43598-484-99 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 43598-484-99 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 43598-484-99 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 43598-484-99 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 43598-484-99 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 43598-484-99 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 43598-484-99 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 43598-484-99 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 43598-484-99 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 43598-484-99 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 43598-484-99 906f6e251498…bf70b80e44f0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212983-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 A212983-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21
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.
Product history page 1 of 2 · 76 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 2026-08-18 06:07:40 2026-07 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212983-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212983-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2020-02-21 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Nicotine Polacrilex
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 2 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 359817 Internal RxNorm lookup 359818 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-484 NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.] 6 Current NDC, Legacy NDC 20240706_003b863c-06b0-715d-ccc2-b7da4deac621.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 · 2 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 43598-484-10 43598048410 4 BOTTLE in 1 CARTON (43598-484-10) / 27 LOZENGE in 1 BOTTLE 4 bottle 2020-09-11 0000-00-00 No No Current 43598-484-12 43598048412 5 BOTTLE in 1 CARTON (43598-484-12) / 24 LOZENGE in 1 BOTTLE 5 bottle 2020-09-11 0000-00-00 No No Current 43598-484-13 43598048413 5 BOTTLE in 1 CARTON (43598-484-13) / 27 LOZENGE in 1 BOTTLE 5 bottle 2020-09-11 0000-00-00 No No Current 43598-484-14 43598048414 6 BOTTLE in 1 CARTON (43598-484-14) / 24 LOZENGE in 1 BOTTLE 6 bottle 2020-09-11 0000-00-00 No No Current 43598-484-16 43598048416 6 BOTTLE in 1 CARTON (43598-484-16) / 27 LOZENGE in 1 BOTTLE 6 bottle 2020-09-11 0000-00-00 No No Current 43598-484-17 43598048417 7 BOTTLE in 1 CARTON (43598-484-17) / 24 LOZENGE in 1 BOTTLE 7 bottle 2020-09-11 0000-00-00 No No Current 43598-484-18 43598048418 7 BOTTLE in 1 CARTON (43598-484-18) / 27 LOZENGE in 1 BOTTLE 7 bottle 2020-09-11 0000-00-00 No No Current 43598-484-19 43598048419 8 BOTTLE in 1 CARTON (43598-484-19) / 24 LOZENGE in 1 BOTTLE 8 bottle 2020-09-11 0000-00-00 No No Current 43598-484-22 43598048422 10 BOTTLE in 1 CARTON (43598-484-22) / 24 LOZENGE in 1 BOTTLE 10 bottle 2020-09-11 0000-00-00 No No Current 43598-484-23 43598048423 8 BOTTLE in 1 CARTON (43598-484-23) / 27 LOZENGE in 1 BOTTLE 8 bottle 2020-09-11 0000-00-00 No No Current 43598-484-24 43598048424 1 BOTTLE in 1 CARTON (43598-484-24) / 24 LOZENGE in 1 BOTTLE 1 bottle 2020-09-11 0000-00-00 No No Current 43598-484-27 43598048427 1 BOTTLE in 1 CARTON (43598-484-27) / 27 LOZENGE in 1 BOTTLE 1 bottle 2020-09-11 0000-00-00 No No Current 43598-484-29 43598048429 10 BOTTLE in 1 CARTON (43598-484-29) / 27 LOZENGE in 1 BOTTLE 10 bottle 2020-09-11 0000-00-00 No No Current 43598-484-48 43598048448 2 BOTTLE in 1 CARTON (43598-484-48) / 24 LOZENGE in 1 BOTTLE 2 bottle 2020-09-11 0000-00-00 No No Current 43598-484-54 43598048454 2 BOTTLE in 1 CARTON (43598-484-54) / 27 LOZENGE in 1 BOTTLE 2 bottle 2020-09-11 0000-00-00 No No Current 43598-484-72 43598048472 3 BOTTLE in 1 CARTON (43598-484-72) / 24 LOZENGE in 1 BOTTLE 3 bottle 2020-09-11 0000-00-00 No No Current 43598-484-73 43598048473 7 BOTTLE in 1 CARTON (43598-484-73) / 24 LOZENGE in 1 BOTTLE 7 bottle 2020-09-11 0000-00-00 No No Current 43598-484-74 43598048474 7 BOTTLE in 1 CARTON (43598-484-74) / 27 LOZENGE in 1 BOTTLE 7 bottle 2020-09-11 0000-00-00 No No Current 43598-484-81 43598048481 3 BOTTLE in 1 CARTON (43598-484-81) / 27 LOZENGE in 1 BOTTLE 3 bottle 2020-09-11 0000-00-00 No No Current 43598-484-96 43598048496 4 BOTTLE in 1 CARTON (43598-484-96) / 24 LOZENGE in 1 BOTTLE 4 bottle 2020-09-11 0000-00-00 No No Current 43598-484-99 43598048499 8333 LOZENGE in 1 POUCH (43598-484-99) 8333 lozenge 21-FEB-20 Current