FDA.reportPublic FDA data

Habitrol Lozenge

Product NDC
43598-984
11-digit product format
435980984
Labeler code
43598
Product ID
43598-984_39fef196-941d-934d-5d3b-88e0f9f9928f
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
2021-11-30
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
Habitrol Lozenge
Brand name suffix
Cherry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817, 359818, 2548896, 2548898

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
43598-984-132024-01-30C16284748780-11030e365-084a-111a-e063-dadaa90a10e2Drug Facts
43598-984-722024-01-30C16284748780-11030e365-084a-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-984-13Habitrol Lozenge Cherry5 in 1 CARTONLOZENGE56
43598-984-13Habitrol Lozenge Cherry27 in 1 BOTTLELOZENGE276
43598-984-72Habitrol Lozenge Cherry24 in 1 BOTTLELOZENGE246
43598-984-72Habitrol Lozenge Cherry3 in 1 CARTONLOZENGE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-984HABITROL LOZENGE CHERRY (NICOTINE POLACRILEX) LOZENGE [DR. REDDY'S LABORATORIES INC.]6Current NDC, Legacy NDC, 4 package rows20240706_5a464242-7d63-141e-808e-c41676cf4b78.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 LozengePSN5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG Oral LozengePSN5a464242-7d63-141e-808e-c41676cf4b786
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
359818nicotine 4 MG Oral LozengeSCD5a464242-7d63-141e-808e-c41676cf4b786
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 TrocheSY5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY5a464242-7d63-141e-808e-c41676cf4b786
359818nicotine 4 MG TrocheSY5a464242-7d63-141e-808e-c41676cf4b786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-984-13435980984135 BOTTLE in 1 CARTON (43598-984-13) / 27 LOZENGE in 1 BOTTLE5 bottle2021-11-300000-00-00NoNoCurrent
43598-984-72435980984723 BOTTLE in 1 CARTON (43598-984-72) / 24 LOZENGE in 1 BOTTLE3 bottle2021-11-300000-00-00NoNoCurrent