NDC 0536-3404

Nicotine Polacrilex

Nicotine Polacrilex

Nicotine Polacrilex is a Buccal Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is Nicotine.

Product ID0536-3404_31646ed3-e82c-4db9-9ff1-a75e5e036d61
NDC0536-3404
Product TypeHuman Otc Drug
Proprietary NameNicotine Polacrilex
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationBUCCAL
Marketing Start Date2009-07-08
Marketing CategoryANDA / ANDA
Application NumberANDA079216
Labeler NameRugby Laboratories, Inc.
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
Pharm ClassesCholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0536-3404-01

100 BLISTER PACK in 1 CARTON (0536-3404-01) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2009-07-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-3404-01 [00536340401]

Nicotine Polacrilex GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA079216
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-07-08

NDC 0536-3404-37 [00536340437]

Nicotine Polacrilex GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA079216
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-07-08
Marketing End Date2014-08-31

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:d67149d5-4766-4b84-8205-f1a6b692f4c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 314119
  • NDC Crossover Matching brand name "Nicotine Polacrilex" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68016-293Nicotine PolacrilexNicotine Polacrilex
    68016-292Nicotine PolacrilexNicotine Polacrilex
    0536-3405Nicotine PolacrilexNicotine Polacrilex
    0536-3404Nicotine PolacrilexNicotine Polacrilex
    11673-229NICOTINE POLACRILEXNICOTINE POLACRILEX
    30142-170nicotine polacrilexnicotine polacrilex
    45802-873Nicotine PolacrilexNicotine Polacrilex
    45802-344Nicotine PolacrilexNicotine Polacrilex
    45802-089Nicotine PolacrilexNicotine Polacrilex
    45802-001Nicotine PolacrilexNicotine Polacrilex
    45802-206Nicotine PolacrilexNicotine Polacrilex
    45802-957Nicotine PolacrilexNicotine Polacrilex
    49035-613Nicotine PolacrilexNicotine Polacrilex
    50090-1152Nicotine PolacrilexNicotine Polacrilex
    50090-1154Nicotine PolacrilexNicotine Polacrilex
    55301-428Nicotine PolacrilexNicotine Polacrilex
    55301-504Nicotine PolacrilexNicotine Polacrilex
    55301-503Nicotine PolacrilexNicotine Polacrilex
    55301-429Nicotine PolacrilexNicotine Polacrilex
    59779-087nicotine polacrilexnicotine polacrilex
    59779-918Nicotine PolacrilexNicotine Polacrilex
    0363-0613Nicotine PolacrilexNicotine Polacrilex
    63868-167Nicotine PolacrilexNicotine Polacrilex
    63868-168Nicotine PolacrilexNicotine Polacrilex
    37808-948nicotine polacrilexnicotine polacrilex
    11822-2331Nicotine PolacrilexNicotine Polacrilex
    11822-3326Nicotine PolacrilexNicotine Polacrilex
    11822-3314Nicotine PolacrilexNicotine Polacrilex
    11822-3313Nicotine PolacrilexNicotine Polacrilex
    11822-2128Nicotine PolacrilexNicotine Polacrilex
    11822-3325Nicotine PolacrilexNicotine Polacrilex
    43598-486Nicotine PolacrilexNicotine Polacrilex
    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

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