FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
43598-485
11-digit product format
435980485
Labeler code
43598
Product ID
43598-485_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
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
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
43598-485-102024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-122024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-132024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-142024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-162024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-172024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-182024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-192024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-222024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-232024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-242024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-272024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-292024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-482024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-542024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-722024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-732024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-742024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-812024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-962024-01-30C16284748780-11030e364-fa18-111a-e063-dadaa90a10e2Drug Facts
43598-485-992021-07-23C16284748780-1c7ccaba7-1e1e-fd44-e053-dadaa90aa01b5cab76ed-d0bf-0dce-d4d2-5603b7efb400

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-485NICOTINE 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
43598-485-10435980485104 BOTTLE in 1 CARTON (43598-485-10) / 27 LOZENGE in 1 BOTTLE4 bottle2020-09-110000-00-00NoNoCurrent
43598-485-12435980485125 BOTTLE in 1 CARTON (43598-485-12) / 24 LOZENGE in 1 BOTTLE5 bottle2020-09-110000-00-00NoNoCurrent
43598-485-13435980485135 BOTTLE in 1 CARTON (43598-485-13) / 27 LOZENGE in 1 BOTTLE5 bottle2020-09-110000-00-00NoNoCurrent
43598-485-14435980485146 BOTTLE in 1 CARTON (43598-485-14) / 24 LOZENGE in 1 BOTTLE6 bottle2020-09-110000-00-00NoNoCurrent
43598-485-16435980485166 BOTTLE in 1 CARTON (43598-485-16) / 27 LOZENGE in 1 BOTTLE6 bottle2020-09-110000-00-00NoNoCurrent
43598-485-17435980485177 BOTTLE in 1 CARTON (43598-485-17) / 24 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-485-18435980485187 BOTTLE in 1 CARTON (43598-485-18) / 27 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-485-19435980485198 BOTTLE in 1 CARTON (43598-485-19) / 24 LOZENGE in 1 BOTTLE8 bottle2020-09-110000-00-00NoNoCurrent
43598-485-224359804852210 BOTTLE in 1 CARTON (43598-485-22) / 24 LOZENGE in 1 BOTTLE10 bottle2020-09-110000-00-00NoNoCurrent
43598-485-23435980485238 BOTTLE in 1 CARTON (43598-485-23) / 27 LOZENGE in 1 BOTTLE8 bottle2020-09-110000-00-00NoNoCurrent
43598-485-24435980485241 BOTTLE in 1 CARTON (43598-485-24) / 24 LOZENGE in 1 BOTTLE1 bottle2020-09-110000-00-00NoNoCurrent
43598-485-27435980485271 BOTTLE in 1 CARTON (43598-485-27) / 27 LOZENGE in 1 BOTTLE1 bottle2020-09-110000-00-00NoNoCurrent
43598-485-294359804852910 BOTTLE in 1 CARTON (43598-485-29) / 27 LOZENGE in 1 BOTTLE10 bottle2020-09-110000-00-00NoNoCurrent
43598-485-48435980485482 BOTTLE in 1 CARTON (43598-485-48) / 24 LOZENGE in 1 BOTTLE2 bottle2020-09-110000-00-00NoNoCurrent
43598-485-54435980485542 BOTTLE in 1 CARTON (43598-485-54) / 27 LOZENGE in 1 BOTTLE2 bottle2020-09-110000-00-00NoNoCurrent
43598-485-72435980485723 BOTTLE in 1 CARTON (43598-485-72) / 24 LOZENGE in 1 BOTTLE3 bottle2020-09-110000-00-00NoNoCurrent
43598-485-73435980485737 BOTTLE in 1 CARTON (43598-485-73) / 24 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-485-74435980485747 BOTTLE in 1 CARTON (43598-485-74) / 27 LOZENGE in 1 BOTTLE7 bottle2020-09-110000-00-00NoNoCurrent
43598-485-81435980485813 BOTTLE in 1 CARTON (43598-485-81) / 27 LOZENGE in 1 BOTTLE3 bottle2020-09-110000-00-00NoNoCurrent
43598-485-96435980485964 BOTTLE in 1 CARTON (43598-485-96) / 24 LOZENGE in 1 BOTTLE4 bottle2020-09-110000-00-00NoNoCurrent
43598-485-99435980485998333 LOZENGE in 1 POUCH (43598-485-99)8333 lozenge21-FEB-20Current