FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
43598-487
11-digit product format
435980487
Labeler code
43598
Product ID
43598-487_33e2c1b3-2ea4-98f4-47c2-320c8ddd608e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA212796
Marketing category
ANDA
Marketing start
2020-06-09
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-487-102024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-122024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-132024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-142024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-162024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-172024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-182024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-192024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-222024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-232024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-242024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-272024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-292024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-482024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-542024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-722024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-732024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-742024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-812024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-962024-01-30C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-992021-12-10C16284748780-1c7ccaba7-2877-fd44-e053-dadaa90aa01b2034ebaf-ad5e-71aa-5757-534f7d2be997
43598-487-102021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-122021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-132021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-142021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-162021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-172021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-182021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-192021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-222021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-232021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-242021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-272021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-292021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-482021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-542021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-722021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-732021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-742021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-812021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-962021-12-09C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-102021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-122021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-132021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-142021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-162021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-172021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-182021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-192021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-222021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-232021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-242021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-272021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-292021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-482021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-542021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-722021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-732021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-742021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-812021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-962021-07-23C16284748780-1c7ccaba7-13f2-fd44-e053-dadaa90aa01bDrug Facts
43598-487-992021-07-23C16284748780-1c7ccaba7-2877-fd44-e053-dadaa90aa01b2034ebaf-ad5e-71aa-5757-534f7d2be997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-487-10EA - Each43598-487f01875fe-a42a-4ba5-a36e-55f920fd31b112020-07-13
43598-487-24EA - Each43598-4875fb6eee1-bf7b-4a87-90f4-551a3c386c2c12020-07-13
43598-487-27EA - Each43598-487488d6ebc-5cf9-4f24-805f-6f9854627b8912020-07-13
43598-487-72EA - Each43598-48736b61a33-f20e-47dc-8ab0-69a62c29101512020-07-13
43598-487-81EA - Each43598-48721f9f10c-7c89-4ef5-a82b-ffd7a6fee62112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-487NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.]7Current NDC, Legacy NDC20240706_b0fdb36d-4cf5-8a91-3da1-90e3587450f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNa3ca2479-9703-41de-918a-881da16e5c98103
359818nicotine 4 MG Oral LozengeSCDa3ca2479-9703-41de-918a-881da16e5c98103
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYa3ca2479-9703-41de-918a-881da16e5c98103
359818nicotine 4 MG TrocheSYa3ca2479-9703-41de-918a-881da16e5c98103
359817nicotine 2 MG Oral LozengePSNb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG Oral LozengePSNb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359817nicotine 2 MG Oral LozengeSCDb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG Oral LozengeSCDb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359817nicotine 2 MG TrocheSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
359818nicotine 4 MG TrocheSYb0fdb36d-4cf5-8a91-3da1-90e3587450f98
2548896Habitrol 2 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
2548898Habitrol 4 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG Oral LozengePSN836bae74-076b-3c92-dee9-22b8519b529d5
2548896nicotine 2 MG Oral Lozenge [Habitrol]SBD836bae74-076b-3c92-dee9-22b8519b529d5
2548898nicotine 4 MG Oral Lozenge [Habitrol]SBD836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG Oral LozengeSCD836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG Oral LozengeSCD836bae74-076b-3c92-dee9-22b8519b529d5
2548896Habitrol 2 MG Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
2548898Habitrol 4 MG Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG TrocheSY836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY836bae74-076b-3c92-dee9-22b8519b529d5
359818nicotine 4 MG TrocheSY836bae74-076b-3c92-dee9-22b8519b529d5
359817nicotine 2 MG Oral LozengePSNe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG Oral LozengePSNe0234492-d92d-ee93-493f-1099d45447224
359817nicotine 2 MG Oral LozengeSCDe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG Oral LozengeSCDe0234492-d92d-ee93-493f-1099d45447224
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYe0234492-d92d-ee93-493f-1099d45447224
359817nicotine 2 MG TrocheSYe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG TrocheSYe0234492-d92d-ee93-493f-1099d45447224
359818nicotine 4 MG Oral LozengePSNdfaf8a76-c5a2-6920-e053-2995a90abc5a1
359818nicotine 4 MG Oral LozengeSCDdfaf8a76-c5a2-6920-e053-2995a90abc5a1
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYdfaf8a76-c5a2-6920-e053-2995a90abc5a1
359818nicotine 4 MG TrocheSYdfaf8a76-c5a2-6920-e053-2995a90abc5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-487-10435980487104 BOTTLE in 1 CARTON (43598-487-10) > 27 LOZENGE in 1 BOTTLE4 bottle2020-06-090000-00-00NoNoCurrent
43598-487-12435980487125 BOTTLE in 1 CARTON (43598-487-12) / 24 LOZENGE in 1 BOTTLE5 bottle2020-06-090000-00-00NoNoCurrent
43598-487-13435980487135 BOTTLE in 1 CARTON (43598-487-13) / 27 LOZENGE in 1 BOTTLE5 bottle2020-06-090000-00-00NoNoCurrent
43598-487-14435980487146 BOTTLE in 1 CARTON (43598-487-14) / 24 LOZENGE in 1 BOTTLE6 bottle2020-06-090000-00-00NoNoCurrent
43598-487-16435980487166 BOTTLE in 1 CARTON (43598-487-16) / 27 LOZENGE in 1 BOTTLE6 bottle2020-06-090000-00-00NoNoCurrent
43598-487-17435980487177 BOTTLE in 1 CARTON (43598-487-17) / 24 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-487-18435980487187 BOTTLE in 1 CARTON (43598-487-18) / 27 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-487-19435980487198 BOTTLE in 1 CARTON (43598-487-19) / 24 LOZENGE in 1 BOTTLE8 bottle2020-06-090000-00-00NoNoCurrent
43598-487-224359804872210 BOTTLE in 1 CARTON (43598-487-22) / 24 LOZENGE in 1 BOTTLE10 bottle2020-06-090000-00-00NoNoCurrent
43598-487-23435980487238 BOTTLE in 1 CARTON (43598-487-23) / 27 LOZENGE in 1 BOTTLE8 bottle2020-06-090000-00-00NoNoCurrent
43598-487-24435980487241 BOTTLE in 1 CARTON (43598-487-24) / 24 LOZENGE in 1 BOTTLE1 bottle2020-06-090000-00-00NoNoCurrent
43598-487-27435980487271 BOTTLE in 1 CARTON (43598-487-27) / 27 LOZENGE in 1 BOTTLE1 bottle2020-06-090000-00-00NoNoCurrent
43598-487-294359804872910 BOTTLE in 1 CARTON (43598-487-29) / 27 LOZENGE in 1 BOTTLE10 bottle2020-06-090000-00-00NoNoCurrent
43598-487-48435980487482 BOTTLE in 1 CARTON (43598-487-48) / 24 LOZENGE in 1 BOTTLE2 bottle2020-06-090000-00-00NoNoCurrent
43598-487-54435980487542 BOTTLE in 1 CARTON (43598-487-54) / 27 LOZENGE in 1 BOTTLE2 bottle2020-06-090000-00-00NoNoCurrent
43598-487-72435980487723 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLE3 bottle2020-06-090000-00-00NoNoCurrent
43598-487-73435980487737 BOTTLE in 1 CARTON (43598-487-73) / 24 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-487-74435980487747 BOTTLE in 1 CARTON (43598-487-74) / 27 LOZENGE in 1 BOTTLE7 bottle2020-06-090000-00-00NoNoCurrent
43598-487-81435980487813 BOTTLE in 1 CARTON (43598-487-81) / 27 LOZENGE in 1 BOTTLE3 bottle2020-06-090000-00-00NoNoCurrent
43598-487-96435980487964 BOTTLE in 1 CARTON (43598-487-96) / 24 LOZENGE in 1 BOTTLE4 bottle2020-06-090000-00-00NoNoCurrent