NDC 68016-811

Premier Value Extra Strength

Simethicone

Premier Value Extra Strength is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Pharmacy Value Alliance, Llc. The primary component is Dimethicone.

Product ID68016-811_347ae3a6-fbce-4980-b80b-908eb94b03f7
NDC68016-811
Product TypeHuman Otc Drug
Proprietary NamePremier Value Extra Strength
Generic NameSimethicone
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2019-05-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart332
Labeler NamePHARMACY VALUE ALLIANCE, LLC
Substance NameDIMETHICONE
Active Ingredient Strength125 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68016-811-18

2 BLISTER PACK in 1 CARTON (68016-811-18) > 9 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date2019-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-811-18 [68016081118]

Premier Value Extra Strength TABLET, CHEWABLE
Marketing CategoryOTC monograph final
Application Numberpart332
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-15

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE125 mg/1

OpenFDA Data

SPL SET ID:df2b1b62-5bd2-4d02-86c2-537b965a8d20
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314221
    • UPC Code
  • 0840986019197

    • NDC Crossover Matching brand name "Premier Value Extra Strength" or generic name "Simethicone"

    NDCBrand NameGeneric Name
    68016-811Premier Value Extra StrengthPremier Value Extra Strength
    0363-0608Extra Strength Gas ReliefSimethicone
    0363-0125Gas ReliefSimethicone
    0363-0487Gas ReliefSIMETHICONE
    0363-0530Gas ReliefSimethicone
    0363-0635Gas ReliefSimethicone
    0067-0116Gas-XSimethicone
    0067-0117Gas-XSimethicone
    0067-0129Gas-XSimethicone
    0067-0134Gas-XSimethicone
    0067-6274Gas-XSimethicone
    0067-6275Gas-XSimethicone
    0067-6283Gas-XSimethicone
    0113-0428Good Sense Gas ReliefSimethicone
    0113-0657good sense gas reliefSimethicone
    0113-0882good sense simethiconeSimethicone
    0113-6011injoy gas reliefSimethicone
    0132-0208PHAZYMESimethicone
    0132-0211PHAZYMESimethicone
    0132-0214PHAZYMESimethicone
    0132-0215PHAZYMESimethicone
    0132-0217PHAZYME ULTIMATESIMETHICONE
    0363-0118WalgreensSimethicone

    Trademark Results [Premier Value]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREMIER VALUE
    PREMIER VALUE
    78208206 3357001 Live/Registered
    PHARMACY VALUE ALLIANCE, LLC
    2003-01-29
    PREMIER VALUE
    PREMIER VALUE
    75164203 2113837 Dead/Cancelled
    MINNESOTA FIRE AND CASUALTY COMPANY
    1996-09-11
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