FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
43598-489
11-digit product format
435980489
Labeler code
43598
Product ID
43598-489_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
4 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
NICOTINE4 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
43598-489-102024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-122024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-132024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-142024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-162024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-172024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-182024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-192024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-222024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-232024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-242024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-272024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-292024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-482024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-542024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-722024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-732024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-742024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-812024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts
43598-489-962024-01-30C16284748780-11030e365-0e87-111a-e063-dadaa90a10e2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-489NICOTINE 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
43598-489-10435980489104 BOTTLE in 1 CARTON (43598-489-10) / 27 LOZENGE in 1 BOTTLE4 bottle2020-10-010000-00-00NoNoCurrent
43598-489-12435980489125 BOTTLE in 1 CARTON (43598-489-12) / 24 LOZENGE in 1 BOTTLE5 bottle2020-10-010000-00-00NoNoCurrent
43598-489-13435980489135 BOTTLE in 1 CARTON (43598-489-13) / 27 LOZENGE in 1 BOTTLE5 bottle2020-10-010000-00-00NoNoCurrent
43598-489-14435980489146 BOTTLE in 1 CARTON (43598-489-14) / 24 LOZENGE in 1 BOTTLE6 bottle2020-10-010000-00-00NoNoCurrent
43598-489-16435980489166 BOTTLE in 1 CARTON (43598-489-16) / 27 LOZENGE in 1 BOTTLE6 bottle2020-10-010000-00-00NoNoCurrent
43598-489-17435980489177 BOTTLE in 1 CARTON (43598-489-17) / 24 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-489-18435980489187 BOTTLE in 1 CARTON (43598-489-18) / 27 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-489-19435980489198 BOTTLE in 1 CARTON (43598-489-19) / 24 LOZENGE in 1 BOTTLE8 bottle2020-10-010000-00-00NoNoCurrent
43598-489-224359804892210 BOTTLE in 1 CARTON (43598-489-22) / 24 LOZENGE in 1 BOTTLE10 bottle2020-10-010000-00-00NoNoCurrent
43598-489-23435980489238 BOTTLE in 1 CARTON (43598-489-23) / 27 LOZENGE in 1 BOTTLE8 bottle2020-10-010000-00-00NoNoCurrent
43598-489-24435980489241 BOTTLE in 1 CARTON (43598-489-24) / 24 LOZENGE in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
43598-489-27435980489271 BOTTLE in 1 CARTON (43598-489-27) / 27 LOZENGE in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
43598-489-294359804892910 BOTTLE in 1 CARTON (43598-489-29) / 27 LOZENGE in 1 BOTTLE10 bottle2020-10-010000-00-00NoNoCurrent
43598-489-48435980489482 BOTTLE in 1 CARTON (43598-489-48) / 24 LOZENGE in 1 BOTTLE2 bottle2020-10-010000-00-00NoNoCurrent
43598-489-54435980489542 BOTTLE in 1 CARTON (43598-489-54) / 27 LOZENGE in 1 BOTTLE2 bottle2020-10-010000-00-00NoNoCurrent
43598-489-72435980489723 BOTTLE in 1 CARTON (43598-489-72) / 24 LOZENGE in 1 BOTTLE3 bottle2020-10-010000-00-00NoNoCurrent
43598-489-73435980489737 BOTTLE in 1 CARTON (43598-489-73) / 24 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-489-74435980489747 BOTTLE in 1 CARTON (43598-489-74) / 27 LOZENGE in 1 BOTTLE7 bottle2020-10-010000-00-00NoNoCurrent
43598-489-81435980489813 BOTTLE in 1 CARTON (43598-489-81) / 27 LOZENGE in 1 BOTTLE3 bottle2020-10-010000-00-00NoNoCurrent
43598-489-96435980489964 BOTTLE in 1 CARTON (43598-489-96) / 24 LOZENGE in 1 BOTTLE4 bottle2020-10-010000-00-00NoNoCurrent
43598-489-99435980489998333 LOZENGE in 1 POUCH (43598-489-99)8333 lozenge01-OCT-20Current