FDA.reportPublic FDA data

nictoine gum

Product NDC
11822-0904
11-digit product format
118220904
Labeler code
11822
Product ID
11822-0904_e2900c34-50d8-4126-a924-531fa34550a3
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA206394
Marketing category
ANDA
Marketing start
2017-01-17
Marketing end
2026-09-30
Substance
NICOTINE
Active strength
2 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
nictoine gum

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0904-1nictoine gum1 in 1 BLISTER PACKGUM, CHEWING17
11822-0904-1nictoine gum20 in 1 CARTONGUM, CHEWING207
11822-0904-2nictoine gum1 in 1 BLISTER PACKGUM, CHEWING17
11822-0904-2nictoine gum100 in 1 CARTONGUM, CHEWING1007
11822-0904-3nictoine gum160 in 1 CARTONGUM, CHEWING1607
11822-0904-3nictoine gum1 in 1 BLISTER PACKGUM, CHEWING17
11822-0904-4nictoine gum120 in 1 CARTONGUM, CHEWING1207
11822-0904-4nictoine gum1 in 1 BLISTER PACKGUM, CHEWING17
11822-0904-5nictoine gum1 in 1 BLISTER PACKGUM, CHEWING17
11822-0904-5nictoine gum10 in 1 CARTONGUM, CHEWING107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0904NICTOINE GUM (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]6Current NDC, Legacy NDC, 10 package rows20250317_6088eea3-f8f0-4f28-8d38-c2209f2d6626.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN6088eea3-f8f0-4f28-8d38-c2209f2d66267
314119nicotine 2 MG Chewing GumSCD6088eea3-f8f0-4f28-8d38-c2209f2d66267
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY6088eea3-f8f0-4f28-8d38-c2209f2d66267

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0904-11182209040120 BLISTER PACK in 1 CARTON (11822-0904-1) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2017-01-172026-09-30NoNoCurrent
11822-0904-211822090402100 BLISTER PACK in 1 CARTON (11822-0904-2) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2017-01-242026-09-30NoNoCurrent
11822-0904-311822090403160 BLISTER PACK in 1 CARTON (11822-0904-3) > 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2017-02-020000-00-00NoNoCurrent
11822-0904-411822090404120 BLISTER PACK in 1 CARTON (11822-0904-4) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2017-04-290000-00-00NoNoCurrent
11822-0904-51182209040510 BLISTER PACK in 1 CARTON (11822-0904-5) > 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2017-09-060000-00-00NoNoCurrent