NDC 60505-7089

Nicotine Transdermal System

Nicotine Transdermal System

Nicotine Transdermal System is a Transdermal Patch, Extended Release in the Human Otc Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Nicotine.

Product ID60505-7089_6e824276-778f-101f-df54-115b27f7c678
NDC60505-7089
Product TypeHuman Otc Drug
Proprietary NameNicotine Transdermal System
Generic NameNicotine Transdermal System
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2019-01-11
Marketing CategoryANDA / ANDA
Application NumberANDA074612
Labeler NameApotex Corp.
Substance NameNICOTINE
Active Ingredient Strength14 mg/24h
Pharm ClassesCholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 60505-7089-0

14 POUCH in 1 CARTON (60505-7089-0) > 1 h in 1 POUCH
Marketing Start Date2019-01-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-7089-0 [60505708900]

Nicotine Transdermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074612
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-01-11

Drug Details

Active Ingredients

IngredientStrength
NICOTINE14 mg/24h

OpenFDA Data

SPL SET ID:762d9a94-d63d-6cdb-e548-b1e0625bb5b1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198031
  • 198030
  • 198029

    • NDC Crossover Matching brand name "Nicotine Transdermal System" or generic name "Nicotine Transdermal System"

    NDCBrand NameGeneric Name
    0363-1240Nicotine Transdermal SystemNicotine Transdermal System
    0363-1241Nicotine Transdermal SystemNicotine Transdermal System
    0363-1242Nicotine Transdermal SystemNicotine Transdermal System
    0363-1243Nicotine Transdermal SystemNicotine Transdermal System
    0363-1244Nicotine Transdermal SystemNicotine Transdermal System
    0363-1245Nicotine Transdermal SystemNicotine Transdermal System
    0363-8000Nicotine Transdermal SystemNicotine Transdermal System
    0363-8001Nicotine Transdermal SystemNicotine Transdermal System
    0363-8002Nicotine Transdermal SystemNicotine Transdermal System
    11822-1603Nicotine Transdermal SystemNicotine Transdermal System
    36800-032Nicotine Transdermal SystemNicotine Transdermal System
    36800-034Nicotine Transdermal SystemNicotine Transdermal System
    36800-038Nicotine Transdermal SystemNicotine Transdermal System
    37808-122Nicotine Transdermal SystemNicotine Transdermal System
    37808-123Nicotine Transdermal SystemNicotine Transdermal System
    37808-460Nicotine Transdermal SystemNicotine Transdermal System
    37808-461Nicotine Transdermal SystemNicotine Transdermal System
    46122-352Nicotine Transdermal SystemNicotine Transdermal System
    68196-194Nicotine transdermal systemNicotine transdermal system
    11673-195NICOTINE TRANSDERMAL SYSTEMNICOTINE TRANSDERMAL SYSTEM
    11673-196NICOTINE TRANSDERMAL SYSTEMNICOTINE TRANSDERMAL SYSTEM
    11673-194NICOTINE TRANSDERMAL SYSTEMNICOTINE TRANSDERMAL SYSTEM
    43598-445NICOTINE TRANSDERMAL SYSTEMNICOTINE TRANSDERMAL SYSTEM
    46122-354Nicotine Transdermal SystemNicotine Transdermal System
    46122-353Nicotine Transdermal SystemNicotine Transdermal System
    46122-568Nicotine Transdermal SystemNicotine Transdermal System
    49035-194NICOTINE TRANSDERMAL SYSTEMNICOTINE TRANSDERMAL SYSTEM
    49035-195NICOTINE TRANSDERMAL SYSTEMNICOTINE TRANSDERMAL SYSTEM
    49035-196NICOTINE TRANSDERMAL SYSTEMNICOTINE TRANSDERMAL SYSTEM
    60505-7065Nicotine Transdermal SystemNicotine Transdermal System
    60505-7064Nicotine Transdermal SystemNicotine Transdermal System
    60505-7066Nicotine Transdermal SystemNicotine Transdermal System
    60505-7089Nicotine Transdermal SystemNicotine Transdermal System
    60505-7090Nicotine Transdermal SystemNicotine Transdermal System
    60505-7088Nicotine Transdermal SystemNicotine Transdermal System
    70000-0511Nicotine Transdermal SystemNicotine Transdermal System
    70000-0512Nicotine Transdermal SystemNicotine Transdermal System
    70000-0510Nicotine Transdermal SystemNicotine Transdermal System
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