NDC 55700-512

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 Lake Erie Medical Dba Quality Care Products Llc. The primary component is Bisacodyl.

Product ID55700-512_26fa7975-1ceb-43fc-a4ad-f8878d0bae55
NDC55700-512
Product TypeHuman Otc Drug
Proprietary NameEnteric Coated Stimulant Laxative
Generic NameBisacodyl
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2011-09-22
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameBISACODYL
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-512-30

30 TABLET, DELAYED RELEASE in 1 BOTTLE (55700-512-30)
Marketing Start Date2017-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-512-30 [55700051230]

Enteric Coated Stimulant Laxative TABLET, DELAYED RELEASE
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-03-31
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
BISACODYL5 mg/1

OpenFDA Data

SPL SET ID:d4a631e5-bc14-405e-8820-583ebb3bd384
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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