NDC 71610-219

Bisacodyl

Bisacodyl

Bisacodyl is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Bisacodyl.

Product ID71610-219_c2ac20c2-20ac-4a0d-86ba-e90c552611ba
NDC71610-219
Product TypeHuman Otc Drug
Proprietary NameBisacodyl
Generic NameBisacodyl
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2018-12-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameBISACODYL
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71610-219-02

2 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-02)
Marketing Start Date2019-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-219-04 [71610021904]

Bisacodyl TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-01-10

NDC 71610-219-03 [71610021903]

Bisacodyl TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-01-21

NDC 71610-219-02 [71610021902]

Bisacodyl TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-02-28

NDC 71610-219-08 [71610021908]

Bisacodyl TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-02-21

NDC 71610-219-20 [71610021920]

Bisacodyl TABLET, COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-06-06

Drug Details

Active Ingredients

IngredientStrength
BISACODYL5 mg/1

OpenFDA Data

SPL SET ID:b5e1a7f8-17ef-4d67-aeea-879603f800a5
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 "Bisacodyl" or generic name "Bisacodyl"

    NDCBrand NameGeneric Name
    0574-7050Bisacodylbisacodyl
    0615-0598BisacodylBisacodyl Enteric Coated
    0904-6748BisacodylBisacodyl
    0904-7142BisacodylBisacodyl
    0904-7927BisacodylBisacodyl
    68016-688BisacodylBisacodyl
    68210-0312BISACODYLBISACODYL
    68784-102BISACODYLBISACODYL
    70518-1864BisacodylBisacodyl
    71610-219BisacodylBisacodyl
    11534-013BisacodylBisacodyl
    11534-156BisacodylBisacodyl
    16103-367BisacodylBisacodyl
    30142-191BisacodylBisacodyl
    37205-102BisacodylBisacodyl
    50730-1004BisacodylBisacodyl
    50730-1016BisacodylBisacodyl
    54162-006BISACODYLBISACODYL
    55154-6704BisacodylBisacodyl
    55700-502BisacodylBisacodyl
    57896-444BISACODYLBISACODYL
    68016-084BisacodylBisacodyl
    11673-182BISACODYLBISACODYL
    68210-3120BisacodylBisacodyl
    68210-4106BisacodylBisacodyl
    69618-058BisacodylBisacodyl
    70518-2997BisacodylBisacodyl
    41226-003BisacodylBisacodyl
    50090-5385BisacodylBisacodyl
    57896-443BisacodylBisacodyl
    0713-0109BISAC-EVACBisacodyl
    0536-1355BiscolaxBisacodyl
    0904-5058Biscolax LaxativeBisacodyl
    0597-0012Dulcolaxbisacodyl
    0597-0052DulcolaxBisacodyl
    0597-0162DulcolaxBisacodyl
    0597-0340Dulcolaxbisacodyl
    0597-0051Dulcolax Pinkbisacodyl
    0597-0169Dulcolax Pinkbisacodyl
    0597-0335Dulcolax Pinkbisacodyl
    0536-3381Enteric Coated Stimulant LaxativeBisacodyl
    0132-0703FleetBisacodyl
    0363-0327Gentle LaxativeBisacodyl
    0363-6760LaxativeBisacodyl
    0904-6407Unit Dose BisacodylBisacodyl
    0363-3011WOMENS GENTLE LAXATIVEBISACODYL
    0363-0676Womens laxativeBisacodyl

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.