NDC 43749-460

Avedana Gentle Laxative

Bisacodyl

Avedana Gentle Laxative is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Unipack, Inc.. The primary component is Bisacodyl.

Product ID43749-460_43a7c845-da84-4a5d-83ca-c43fbbad694f
NDC43749-460
Product TypeHuman Otc Drug
Proprietary NameAvedana Gentle Laxative
Generic NameBisacodyl
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2017-09-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameUnipack, Inc.
Substance NameBISACODYL
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 43749-460-16

4 BLISTER PACK in 1 CARTON (43749-460-16) > 4 SUPPOSITORY in 1 BLISTER PACK (43749-460-17)
Marketing Start Date2017-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43749-460-17 [43749046017]

Gentle Laxative SUPPOSITORY
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-17

NDC 43749-460-16 [43749046016]

Gentle Laxative SUPPOSITORY
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-17

Drug Details

Active Ingredients

IngredientStrength
BISACODYL10 mg/2000mg

OpenFDA Data

SPL SET ID:e2824884-515a-4a87-bffe-c9d0e97c6c8b
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]
    • UPC Code
  • 0050428541678
    • NUI Code
  • N0000009371
  • N0000175812
  • N0000009871

    • NDC Crossover Matching brand name "Avedana Gentle Laxative" or generic name "Bisacodyl"

    NDCBrand NameGeneric Name
    43749-460Avedana Gentle LaxativeAvedana Gentle 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
    0536-3381Enteric Coated Stimulant LaxativeBisacodyl
    0132-0703FleetBisacodyl
    0363-0327Gentle LaxativeBisacodyl
    0363-6760LaxativeBisacodyl
    0904-6407Unit Dose BisacodylBisacodyl
    0363-3011WOMENS GENTLE LAXATIVEBISACODYL
    0363-0676Womens laxativeBisacodyl
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