NDC 70518-1616

Enteric Coated Stimulant Laxative

Bisacodyl

Enteric Coated Stimulant Laxative is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Bisacodyl.

Product ID70518-1616_798e7cb8-0016-edb2-e053-2a91aa0a3828
NDC70518-1616
Product TypeHuman Otc Drug
Proprietary NameEnteric Coated Stimulant Laxative
Generic NameBisacodyl
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-10-30
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameREMEDYREPACK INC.
Substance NameBISACODYL
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1616-0

30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1616-0)
Marketing Start Date2018-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1616-0 [70518161600]

Enteric Coated Stimulant Laxative TABLET, DELAYED RELEASE
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-30
Marketing End Date2020-05-27

Drug Details

Active Ingredients

IngredientStrength
BISACODYL5 mg/1

OpenFDA Data

SPL SET ID:2c0f8f8e-f69c-40e8-a41c-9e3d5c8cdd52
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308753
  • Pharm Class PE
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
  • Increased Large Intestinal Motility [PE]
  • PHarm Class EPC
  • Stimulant Laxative [EPC]
  • NUI Code
  • N0000009371
  • N0000175812
  • N0000009871
  • NDC Crossover Matching brand name "Enteric Coated Stimulant Laxative" or generic name "Bisacodyl"

    NDCBrand NameGeneric Name
    0536-3381Enteric Coated Stimulant LaxativeBisacodyl
    70518-1616Enteric Coated Stimulant LaxativeEnteric Coated Stimulant Laxative
    33261-178Enteric Coated Stimulant LaxativeEnteric Coated Stimulant Laxative
    55700-512Enteric Coated Stimulant LaxativeEnteric Coated Stimulant Laxative
    63629-3049Enteric Coated Stimulant LaxativeEnteric Coated Stimulant Laxative
    0713-0109BISAC-EVACBisacodyl
    0574-7050Bisacodylbisacodyl
    0904-6748BisacodylBisacodyl
    0904-7142BisacodylBisacodyl
    0904-7927BisacodylBisacodyl
    0536-1355BiscolaxBisacodyl
    0904-5058Biscolax LaxativeBisacodyl
    10237-906Carters Little PillsBisacodyl
    0597-0012Dulcolaxbisacodyl
    0597-0052DulcolaxBisacodyl
    0597-0162DulcolaxBisacodyl
    0597-0340Dulcolaxbisacodyl
    0597-0051Dulcolax Pinkbisacodyl
    0597-0169Dulcolax Pinkbisacodyl
    0597-0335Dulcolax Pinkbisacodyl
    0132-0703FleetBisacodyl
    0363-0327Gentle LaxativeBisacodyl
    0363-6760LaxativeBisacodyl
    0904-6407Unit Dose BisacodylBisacodyl
    0363-3011WOMENS GENTLE LAXATIVEBISACODYL
    0363-0676Womens laxativeBisacodyl

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