NDC 72484-428

Nicotine Polacrilex coated mint

Nicotine Polacrilex

Nicotine Polacrilex coated mint is a Buccal Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Roman Health Ventures Inc.. The primary component is Nicotine.

Product ID72484-428_956fb87b-f80a-6372-e053-2a95a90ac9ae
NDC72484-428
Product TypeHuman Otc Drug
Proprietary NameNicotine Polacrilex coated mint
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationBUCCAL
Marketing Start Date2018-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA078699
Labeler NameRoman Health Ventures Inc.
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72484-428-16

160 BLISTER PACK in 1 CARTON (72484-428-16) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2018-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72484-428-16 [72484042816]

Nicotine Polacrilex coated mint GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA078699
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-08

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

OpenFDA Data

SPL SET ID:d60f90a5-10ea-442b-9ec5-2f2a69ec6441
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 314119
    • UPC Code
  • 0058549024070
  • 0058548287742

    • NDC Crossover Matching brand name "Nicotine Polacrilex coated mint" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    68016-281Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    68016-285Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    68016-284Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    68016-280Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    68016-559Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    68016-560Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    69842-428Nicotine Polacrilex coated mintNicotine Polacrilex coated mint
    69842-430Nicotine Polacrilex coated mintNicotine Polacrilex coated mint
    70000-0343Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    70000-0347Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    72484-429Nicotine Polacrilex coated mintNicotine Polacrilex coated mint
    72484-428Nicotine Polacrilex coated mintNicotine Polacrilex coated mint
    56062-428Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    56062-429Nicotine Polacrilex Coated MintNicotine Polacrilex Coated Mint
    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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