FDA.reportPublic FDA data

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

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-484-102024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-122024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-132024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-142024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-162024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-172024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-182024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-192024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-222024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-232024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-242024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-272024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-292024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-482024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-542024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-722024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-732024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-742024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-812024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-962024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-484-992021-07-23C16284748780-1c7ccaba7-1e1e-fd44-e053-dadaa90aa01b5cab76ed-d0bf-0dce-d4d2-5603b7efb400

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-484NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.]6Current NDC, Legacy NDC20240706_003b863c-06b0-715d-ccc2-b7da4deac621.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG Oral LozengePSN003b863c-06b0-715d-ccc2-b7da4deac6216
359817nicotine 2 MG Oral LozengeSCD003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG Oral LozengeSCD003b863c-06b0-715d-ccc2-b7da4deac6216
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY003b863c-06b0-715d-ccc2-b7da4deac6216
359817nicotine 2 MG TrocheSY003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY003b863c-06b0-715d-ccc2-b7da4deac6216
359818nicotine 4 MG TrocheSY003b863c-06b0-715d-ccc2-b7da4deac6216
2548896Habitrol 2 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
2548898Habitrol 4 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG Oral LozengePSN87714b79-05b3-f3c2-6505-5923e4f488715
2548896nicotine 2 MG Oral Lozenge [Habitrol]SBD87714b79-05b3-f3c2-6505-5923e4f488715
2548898nicotine 4 MG Oral Lozenge [Habitrol]SBD87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG Oral LozengeSCD87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG Oral LozengeSCD87714b79-05b3-f3c2-6505-5923e4f488715
2548896Habitrol 2 MG Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
2548898Habitrol 4 MG Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
359817nicotine 2 MG TrocheSY87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY87714b79-05b3-f3c2-6505-5923e4f488715
359818nicotine 4 MG TrocheSY87714b79-05b3-f3c2-6505-5923e4f488715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-484-10435980484104 BOTTLE in 1 CARTON (43598-484-10) / 27 LOZENGE in 1 BOTTLE4 bottle2020-09-110000-00-00NoNoCurrent
43598-484-12435980484125 BOTTLE in 1 CARTON (43598-484-12) / 24 LOZENGE in 1 BOTTLE5 bottle2020-09-110000-00-00NoNoCurrent
43598-484-13435980484135 BOTTLE in 1 CARTON (43598-484-13) / 27 LOZENGE in 1 BOTTLE5 bottle2020-09-110000-00-00NoNoCurrent
43598-484-14435980484146 BOTTLE in 1 CARTON (43598-484-14) / 24 LOZENGE in 1 BOTTLE6 bottle2020-09-110000-00-00NoNoCurrent
43598-484-16435980484166 BOTTLE in 1 CARTON (43598-484-16) / 27 LOZENGE in 1 BOTTLE6 bottle2020-09-110000-00-00NoNoCurrent
43598-484-17435980484177 BOTTLE in 1 CARTON (43598-484-17) / 24 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-484-18435980484187 BOTTLE in 1 CARTON (43598-484-18) / 27 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-484-19435980484198 BOTTLE in 1 CARTON (43598-484-19) / 24 LOZENGE in 1 BOTTLE8 bottle2020-09-110000-00-00NoNoCurrent
43598-484-224359804842210 BOTTLE in 1 CARTON (43598-484-22) / 24 LOZENGE in 1 BOTTLE10 bottle2020-09-110000-00-00NoNoCurrent
43598-484-23435980484238 BOTTLE in 1 CARTON (43598-484-23) / 27 LOZENGE in 1 BOTTLE8 bottle2020-09-110000-00-00NoNoCurrent
43598-484-24435980484241 BOTTLE in 1 CARTON (43598-484-24) / 24 LOZENGE in 1 BOTTLE1 bottle2020-09-110000-00-00NoNoCurrent
43598-484-27435980484271 BOTTLE in 1 CARTON (43598-484-27) / 27 LOZENGE in 1 BOTTLE1 bottle2020-09-110000-00-00NoNoCurrent
43598-484-294359804842910 BOTTLE in 1 CARTON (43598-484-29) / 27 LOZENGE in 1 BOTTLE10 bottle2020-09-110000-00-00NoNoCurrent
43598-484-48435980484482 BOTTLE in 1 CARTON (43598-484-48) / 24 LOZENGE in 1 BOTTLE2 bottle2020-09-110000-00-00NoNoCurrent
43598-484-54435980484542 BOTTLE in 1 CARTON (43598-484-54) / 27 LOZENGE in 1 BOTTLE2 bottle2020-09-110000-00-00NoNoCurrent
43598-484-72435980484723 BOTTLE in 1 CARTON (43598-484-72) / 24 LOZENGE in 1 BOTTLE3 bottle2020-09-110000-00-00NoNoCurrent
43598-484-73435980484737 BOTTLE in 1 CARTON (43598-484-73) / 24 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-484-74435980484747 BOTTLE in 1 CARTON (43598-484-74) / 27 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-484-81435980484813 BOTTLE in 1 CARTON (43598-484-81) / 27 LOZENGE in 1 BOTTLE3 bottle2020-09-110000-00-00NoNoCurrent
43598-484-96435980484964 BOTTLE in 1 CARTON (43598-484-96) / 24 LOZENGE in 1 BOTTLE4 bottle2020-09-110000-00-00NoNoCurrent
43598-484-99435980484998333 LOZENGE in 1 POUCH (43598-484-99)8333 lozenge21-FEB-20Current