FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
57237-323
11-digit product format
572370323
Labeler code
57237
Product ID
57237-323_9230a5f3-bfa3-4a70-8e91-8df2736d9a29
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078697
Marketing category
ANDA
Marketing start
2023-08-10
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
Rxcui311975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-323-01Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING13
57237-323-01Nicotine Polacrilex100 in 1 CARTONGUM, CHEWING1003
57237-323-11Nicotine Polacrilex110 in 1 CARTONGUM, CHEWING1103
57237-323-11Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING13
57237-323-50Nicotine Polacrilex50 in 1 CARTONGUM, CHEWING503
57237-323-50Nicotine Polacrilex1 in 1 BLISTER PACKGUM, CHEWING13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-323-01EA - Each57237-3236fd67b91-0297-4e50-937a-1d9ea6b78ecf12023-10-16
57237-323-11EA - Each57237-3230609fca6-8393-407b-acd4-82a4836cfb8612026-01-08
57237-323-50EA - Each57237-3237362cc03-6092-464d-be12-3991db20765812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-323NICOTINE POLACRILEX GUM, CHEWING [RISING PHARMA HOLDINGS, INC.]2Current NDC, 6 package rows20240906_e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNe86b9c22-7ee0-4bd0-adfd-a7b087b1dd713
311975nicotine 4 MG Chewing GumSCDe86b9c22-7ee0-4bd0-adfd-a7b087b1dd713
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYe86b9c22-7ee0-4bd0-adfd-a7b087b1dd713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-323-0157237032301100 BLISTER PACK in 1 CARTON (57237-323-01) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2023-08-10NoNoCurrent
57237-323-1157237032311110 BLISTER PACK in 1 CARTON (57237-323-11) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2025-12-08NoNoCurrent
57237-323-505723703235050 BLISTER PACK in 1 CARTON (57237-323-50) / 1 GUM, CHEWING in 1 BLISTER PACK50 blister pack2025-12-08NoNoCurrent