NDC 49781-131

Leader Gentle Laxative

Bisacodyl

Leader Gentle Laxative is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Bisacodyl.

• Product ID: 49781-131_94b715e1-31cc-4bcf-b1d9-3648a9182bc8
• NDC: 49781-131
• Product Type: Human Otc Drug
• Proprietary Name: Leader Gentle Laxative
• Generic Name: Bisacodyl
• Dosage Form: Suppository
• Route of Administration: RECTAL
• Marketing Start Date: 2015-02-13
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part334
• Labeler Name: Cardinal Health
• Substance Name: BISACODYL
• Active Ingredient Strength: 10 mg/2000mg
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 49781-131-16

4 BLISTER PACK in 1 CARTON (49781-131-16) > 40 mg in 1 BLISTER PACK

• Marketing Start Date: 2015-02-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49781-131-16 [49781013116]

Leader Gentle Laxative SUPPOSITORY

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-13
• Marketing End Date: 2020-05-20
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-15

Drug Details

Active Ingredients

Ingredient	Strength
BISACODYL	10 mg/2000mg

OpenFDA Data

• SPL SET ID: 58a32988-3500-4775-afbf-761ee40fa258
• Manufacturer:
  • Cardinal Health
• UNII:
  • 10X0709Y6I
• 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:
  • 0096295126464
• NUI Code:
  • N0000009371
  • N0000175812
  • N0000009871

NDC Crossover Matching brand name "Leader Gentle Laxative" or generic name "Bisacodyl"

NDC	Brand Name	Generic Name
0904-6981	Leader Gentle Laxative	Bisacodyl Suppository
49781-131	Leader Gentle Laxative	Leader Gentle Laxative
70000-0451	Leader Gentle Laxative	Leader Gentle Laxative
0713-0109	BISAC-EVAC	Bisacodyl
0574-7050	Bisacodyl	bisacodyl
0904-6748	Bisacodyl	Bisacodyl
0536-1355	Biscolax	Bisacodyl
0904-5058	Biscolax Laxative	Bisacodyl
0597-0012	Dulcolax	bisacodyl
0597-0052	Dulcolax	Bisacodyl
0597-0162	Dulcolax	Bisacodyl
0597-0340	Dulcolax	bisacodyl
0597-0051	Dulcolax Pink	bisacodyl
0597-0169	Dulcolax Pink	bisacodyl
0597-0335	Dulcolax Pink	bisacodyl
0536-3381	Enteric Coated Stimulant Laxative	Bisacodyl
0132-0703	Fleet	Bisacodyl
0363-0327	Gentle Laxative	Bisacodyl
0363-6760	Laxative	Bisacodyl
0904-6407	Unit Dose Bisacodyl	Bisacodyl
0363-3011	WOMENS GENTLE LAXATIVE	BISACODYL
0363-0676	Womens laxative	Bisacodyl