FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
43598-488
11-digit product format
435980488
Labeler code
43598
Product ID
43598-488_ea14d88d-2ad8-b2e9-bf8f-8a299e66d618
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA213233
Marketing category
ANDA
Marketing start
2020-10-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817, 359818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-488-102024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-122024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-132024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-142024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-162024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-172024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-182024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-192024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-222024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-232024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-242024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-272024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-292024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-482024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-542024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-722024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-732024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-742024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-812024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-488-962024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-488NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.]6Current NDC, Legacy NDC20240706_6b0342dd-120f-a16e-098a-dc45b14d3d3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2548896Habitrol 2 MG Oral LozengePSN5a464242-7d63-141e-808e-c41676cf4b786
2548898Habitrol 4 MG Oral LozengePSN5a464242-7d63-141e-808e-c41676cf4b786
359817nicotine 2 MG Oral LozengePSN6b0342dd-120f-a16e-098a-dc45b14d3d3a6
359817nicotine 2 MG Oral LozengePSN5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG Oral LozengePSN5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG Oral LozengePSN6b0342dd-120f-a16e-098a-dc45b14d3d3a6
2548896nicotine 2 MG Oral Lozenge [Habitrol]SBD5a464242-7d63-141e-808e-c41676cf4b786
2548898nicotine 4 MG Oral Lozenge [Habitrol]SBD5a464242-7d63-141e-808e-c41676cf4b786
359817nicotine 2 MG Oral LozengeSCD5a464242-7d63-141e-808e-c41676cf4b786
359817nicotine 2 MG Oral LozengeSCD6b0342dd-120f-a16e-098a-dc45b14d3d3a6
359818nicotine 4 MG Oral LozengeSCD5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG Oral LozengeSCD6b0342dd-120f-a16e-098a-dc45b14d3d3a6
2548896Habitrol 2 MG Oral LozengeSY5a464242-7d63-141e-808e-c41676cf4b786
2548898Habitrol 4 MG Oral LozengeSY5a464242-7d63-141e-808e-c41676cf4b786
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY5a464242-7d63-141e-808e-c41676cf4b786
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY6b0342dd-120f-a16e-098a-dc45b14d3d3a6
359817nicotine 2 MG TrocheSY6b0342dd-120f-a16e-098a-dc45b14d3d3a6
359817nicotine 2 MG TrocheSY5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY6b0342dd-120f-a16e-098a-dc45b14d3d3a6
359818nicotine 4 MG TrocheSY6b0342dd-120f-a16e-098a-dc45b14d3d3a6
359818nicotine 4 MG TrocheSY5a464242-7d63-141e-808e-c41676cf4b786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-488-10435980488104 BOTTLE in 1 CARTON (43598-488-10) / 27 LOZENGE in 1 BOTTLE4 bottle2020-10-010000-00-00NoNoCurrent
43598-488-12435980488125 BOTTLE in 1 CARTON (43598-488-12) / 24 LOZENGE in 1 BOTTLE5 bottle2020-10-010000-00-00NoNoCurrent
43598-488-13435980488135 BOTTLE in 1 CARTON (43598-488-13) / 27 LOZENGE in 1 BOTTLE5 bottle2020-10-010000-00-00NoNoCurrent
43598-488-14435980488146 BOTTLE in 1 CARTON (43598-488-14) / 24 LOZENGE in 1 BOTTLE6 bottle2020-10-010000-00-00NoNoCurrent
43598-488-16435980488166 BOTTLE in 1 CARTON (43598-488-16) / 27 LOZENGE in 1 BOTTLE6 bottle2020-10-010000-00-00NoNoCurrent
43598-488-17435980488177 BOTTLE in 1 CARTON (43598-488-17) / 24 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-488-18435980488187 BOTTLE in 1 CARTON (43598-488-18) / 27 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-488-19435980488198 BOTTLE in 1 CARTON (43598-488-19) / 24 LOZENGE in 1 BOTTLE8 bottle2020-10-010000-00-00NoNoCurrent
43598-488-224359804882210 BOTTLE in 1 CARTON (43598-488-22) / 24 LOZENGE in 1 BOTTLE10 bottle2020-10-010000-00-00NoNoCurrent
43598-488-23435980488238 BOTTLE in 1 CARTON (43598-488-23) / 27 LOZENGE in 1 BOTTLE8 bottle2020-10-010000-00-00NoNoCurrent
43598-488-24435980488241 BOTTLE in 1 CARTON (43598-488-24) / 24 LOZENGE in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
43598-488-27435980488271 BOTTLE in 1 CARTON (43598-488-27) / 27 LOZENGE in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
43598-488-294359804882910 BOTTLE in 1 CARTON (43598-488-29) / 27 LOZENGE in 1 BOTTLE10 bottle2020-10-010000-00-00NoNoCurrent
43598-488-48435980488482 BOTTLE in 1 CARTON (43598-488-48) / 24 LOZENGE in 1 BOTTLE2 bottle2020-10-010000-00-00NoNoCurrent
43598-488-54435980488542 BOTTLE in 1 CARTON (43598-488-54) / 27 LOZENGE in 1 BOTTLE2 bottle2020-10-010000-00-00NoNoCurrent
43598-488-72435980488723 BOTTLE in 1 CARTON (43598-488-72) / 24 LOZENGE in 1 BOTTLE3 bottle2020-10-010000-00-00NoNoCurrent
43598-488-73435980488737 BOTTLE in 1 CARTON (43598-488-73) / 24 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-488-74435980488747 BOTTLE in 1 CARTON (43598-488-74) / 27 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-488-81435980488813 BOTTLE in 1 CARTON (43598-488-81) / 27 LOZENGE in 1 BOTTLE3 bottle2020-10-010000-00-00NoNoCurrent
43598-488-96435980488964 BOTTLE in 1 CARTON (43598-488-96) / 24 LOZENGE in 1 BOTTLE4 bottle2020-10-010000-00-00NoNoCurrent
43598-488-99435980488998333 LOZENGE in 1 POUCH (43598-488-99)8333 lozenge01-OCT-20Current