NDC 70795-1010

LAXATIVE

Bisacodyl

LAXATIVE is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Graxcell Pharmaceutical, Llc. The primary component is Bisacodyl.

Product ID70795-1010_bac72606-1ec2-4532-9c63-c5fd55288c71
NDC70795-1010
Product TypeHuman Otc Drug
Proprietary NameLAXATIVE
Generic NameBisacodyl
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2017-03-29
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameGRAXCELL PHARMACEUTICAL, LLC
Substance NameBISACODYL
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70795-1010-1

100 BLISTER PACK in 1 PACKAGE (70795-1010-1) > 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date2017-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70795-1010-8 [70795101008]

LAXATIVE SUPPOSITORY
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-03-29
Inactivation Date2020-01-31

NDC 70795-1010-5 [70795101005]

LAXATIVE SUPPOSITORY
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-04-22
Inactivation Date2020-01-31

NDC 70795-1010-1 [70795101001]

LAXATIVE SUPPOSITORY
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-04-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BISACODYL10 mg/1

OpenFDA Data

SPL SET ID:5a65d4ab-447f-42bb-b38d-070db523b806
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198509
  • 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 "LAXATIVE" or generic name "Bisacodyl"

    NDCBrand NameGeneric Name
    0363-0347LaxativeSennosides
    0363-3480LaxativeSennosides
    0363-6550LaxativeDocusate Sodium
    0363-6760LaxativeBisacodyl
    68016-726LaxativeLaxative
    69168-226LaxativeLaxative
    70000-0443LaxativeLaxative
    70795-1010LAXATIVELAXATIVE
    11822-0306LaxativeLaxative
    11822-0327LaxativeLaxative
    15127-178LaxativeLaxative
    21130-327LaxativeLaxative
    33992-0327LaxativeLaxative
    49035-348LaxativeLaxative
    50845-0181LaxativeLaxative
    55315-369LAXATIVELAXATIVE
    55319-327LaxativeLaxative
    55301-676LaxativeLaxative
    55315-190LaxativeLaxative
    55319-195LaxativeLaxative
    55316-190LaxativeLaxative
    62011-0159LaxativeLaxative
    62011-0277laxativelaxative
    63868-328LaxativeLaxative
    63868-572LaxativeLaxative
    0713-0109BISAC-EVACBisacodyl
    0574-7050Bisacodylbisacodyl
    0536-1355BiscolaxBisacodyl
    0904-5058Biscolax LaxativeBisacodyl
    0283-0808CEO-TWOLaxative
    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
    0363-3011WOMENS GENTLE LAXATIVEBISACODYL
    0363-0676Womens laxativeBisacodyl

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