nicotine

Product NDC
11822-1103
11-digit product format
118221103
Labeler code
11822
Product ID
11822-1103_8ddb8f3f-d928-4396-94d1-abce0f0bffac
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA206393
Marketing category
ANDA
Marketing start
2023-06-26
Marketing end
2026-09-30
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine

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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1103-0nicotine20 in 1 CARTONGUM, CHEWING204
11822-1103-0nicotine1 in 1 BLISTER PACKGUM, CHEWING14
11822-1103-1nicotine100 in 1 CARTONGUM, CHEWING1004
11822-1103-1nicotine1 in 1 BLISTER PACKGUM, CHEWING14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1103NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]3Current NDC, 4 package rows20250507_f5f813aa-80f5-410c-9b16-416e955c02a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNf5f813aa-80f5-410c-9b16-416e955c02a94
311975nicotine 4 MG Chewing GumSCDf5f813aa-80f5-410c-9b16-416e955c02a94
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYf5f813aa-80f5-410c-9b16-416e955c02a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1103-01182211030020 BLISTER PACK in 1 CARTON (11822-1103-0) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2023-08-292026-09-30NoNoHistorical
11822-1103-111822110301100 BLISTER PACK in 1 CARTON (11822-1103-1) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2023-06-262026-09-30NoNoHistorical