NDC 52389-154

Pep-Back Ultra

Caffeine

Pep-Back Ultra is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Alva-amco Pharmacal Companies, Inc.. The primary component is Caffeine.

Product ID52389-154_7d3c490b-dbf0-8f74-e053-2a91aa0ac399
NDC52389-154
Product TypeHuman Otc Drug
Proprietary NamePep-Back Ultra
Generic NameCaffeine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1993-04-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart340
Labeler NameAlva-Amco Pharmacal Companies, Inc.
Substance NameCAFFEINE
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52389-154-18

2 BLISTER PACK in 1 CARTON (52389-154-18) > 9 TABLET, FILM COATED in 1 BLISTER PACK (52389-154-09)
Marketing Start Date2011-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52389-154-18 [52389015418]

Pep-Back Ultra TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart340
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-03-01
Marketing End Date2018-08-31

NDC 52389-154-09 [52389015409]

Pep-Back Ultra TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart340
Product TypeHUMAN OTC DRUG
Marketing Start Date1993-04-08
Marketing End Date2018-08-31

NDC 52389-154-12 [52389015412]

Pep-Back Ultra TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart340
Product TypeHUMAN OTC DRUG
Marketing Start Date1993-04-08
Marketing End Date2018-08-31

NDC 52389-154-36 [52389015436]

Pep-Back Ultra TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart340
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-09-15
Marketing End Date2012-06-12

Drug Details

Active Ingredients

IngredientStrength
CAFFEINE200 mg/1

OpenFDA Data

SPL SET ID:f9759c55-5d57-4fc4-9fa4-97fc117ab42e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198520
  • 747241
    • UPC Code
  • 0072959540180

    • NDC Crossover Matching brand name "Pep-Back Ultra" or generic name "Caffeine"

    NDCBrand NameGeneric Name
    52389-154Pep-Back UltraPep-Back Ultra
    0363-3440AwakeCaffeine
    21130-944AwakeCaffeine
    0363-5009CaffeineCaffeine
    24385-601Good Neighbor Pharmacy Stay AwakeCaffeine
    0113-0409good sense stay awakeCaffeine
    15579-201JET ALERT Regular StrengthCAFFEINE
    0067-2070NoDozCaffeine
    15127-226Stay AlertCaffeine
    0363-0226Stay AwakeCaffeine
    0904-7955Stay AwakeCaffeine
    11822-0691Stay AwakeCaffeine
    11822-2260stay awakecaffeine
    21130-226Stay AwakeCaffeine
    30142-409stay awakeCaffeine
    30142-726Stay AwakeCaffeine

    Trademark Results [Pep-Back]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEP-BACK
    PEP-BACK
    73281787 1191043 Live/Registered
    Gerchenson; Emile H.
    1980-10-14
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.