NDC 11822-3322

Nicotine Polacrilex Gum

Nicotine Polacrilex

Nicotine Polacrilex Gum is a Buccal Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Rite Aid Corporation. The primary component is Nicotine.

Product ID11822-3322_202f76af-0ef5-4e27-b194-b198c8379b13
NDC11822-3322
Product TypeHuman Otc Drug
Proprietary NameNicotine Polacrilex Gum
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationBUCCAL
Marketing Start Date2020-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA079044
Labeler NameRite Aid Corporation
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
Pharm ClassesCholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 11822-3322-3

20 BLISTER PACK in 1 CARTON (11822-3322-3) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2020-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11822-3322-9 [11822332209]

Nicotine Polacrilex Gum GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA079044
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

NDC Crossover Matching brand name "Nicotine Polacrilex Gum" or generic name "Nicotine Polacrilex"

NDCBrand NameGeneric Name
11822-3322Nicotine Polacrilex GumNicotine Polacrilex Gum
0113-0704basic care nicotineNicotine polacrilex
0113-0713basic care nicotineNicotine Polacrilex
0113-0749basic care nicotineNicotine Polacrilex
0113-0761basic care nicotineNicotine Polacrilex
0113-7007basic care nicotineNicotine Polacrilex
0113-7008basic care nicotinenicotine polacrilex
0113-7029basic care nicotineNicotine Polacrilex
0113-0029Good Sense NicotineNicotine Polacrilex
0113-0053Good Sense NicotineNicotine Polacrilex
0113-0170Good Sense NicotineNicotine Polacrilex
0113-0206good sense nicotineNicotine Polacrilex
0113-0344Good Sense NicotineNicotine Polacrilex
0113-0422Good Sense NicotineNicotine Polacrilex
0113-0456Good Sense NicotineNicotine Polacrilex
0113-0532Good Sense NicotineNicotine Polacrilex
0113-0734Good Sense NicotineNicotine Polacrilex
0113-0854Good Sense NicotineNicotine polacrilex
0113-0873good sense nicotineNicotine Polacrilex
0113-0957Good Sense NicotineNicotine Polacrilex
0113-1125Good Sense NicotineNicotine Polacrilex
0113-1190good sense nicotineNicotine Polacrilex
0113-1352good sense nicotineNicotine Polacrilex
0113-6000Tru Relief NicotineNicotine Polacrilex
0113-6001Tru Relief NicotineNicotine Polacrilex

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