FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
45802-873
11-digit product format
458020873
Labeler code
45802
Product ID
45802-873_574b2fe4-a95b-400d-a107-4658e84f7d87
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA077007
Marketing category
ANDA
Marketing start
2014-03-31
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
Rxcui359818

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-873-03Nicotine Polacrilex24 in 1 CONTAINERLOZENGE246
45802-873-05Nicotine Polacrilex3 in 1 CARTONLOZENGE36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-873-03EA - Each45802-873753e6cf1-f5ce-420f-9076-d2beac103eef12025-10-14
45802-873-05EA - Each45802-873cfb4c721-af2d-4d5f-8a74-a2fb15a2e5c612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1NICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-873NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 2 package rows20250116_8d4dfba9-1571-4128-9cdc-47cdce04e3e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNbee5365b-e7f1-493a-baec-8604bd5550e312
359818nicotine 4 MG Oral LozengeSCDbee5365b-e7f1-493a-baec-8604bd5550e312
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYbee5365b-e7f1-493a-baec-8604bd5550e312
359818nicotine 4 MG TrocheSYbee5365b-e7f1-493a-baec-8604bd5550e312
359818nicotine 4 MG Oral LozengePSN8d4dfba9-1571-4128-9cdc-47cdce04e3e46
359818nicotine 4 MG Oral LozengeSCD8d4dfba9-1571-4128-9cdc-47cdce04e3e46
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY8d4dfba9-1571-4128-9cdc-47cdce04e3e46
359818nicotine 4 MG TrocheSY8d4dfba9-1571-4128-9cdc-47cdce04e3e46
359818nicotine 4 MG Oral LozengePSN49125b9b-8ccd-b122-e063-6394a90a483c2
359818nicotine 4 MG Oral LozengeSCD49125b9b-8ccd-b122-e063-6394a90a483c2
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY49125b9b-8ccd-b122-e063-6394a90a483c2
359818nicotine 4 MG TrocheSY49125b9b-8ccd-b122-e063-6394a90a483c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-873-034580208730324 in 1 CONTAINERHistorical
45802-873-05458020873053 CONTAINER in 1 CARTON (45802-873-05) / 24 LOZENGE in 1 CONTAINER (45802-873-03) 3 container2014-03-310000-00-00NoNoCurrent