NDC 0536-3381

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 Rugby Laboratories, Inc. The primary component is Bisacodyl.

• Product ID: 0536-3381_28a65991-a53d-4e04-8253-9a9d0c49bf57
• NDC: 0536-3381
• Product Type: Human Otc Drug
• Proprietary Name: Enteric Coated Stimulant Laxative
• Generic Name: Bisacodyl
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2011-09-22
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part334
• Labeler Name: Rugby Laboratories, Inc
• Substance Name: BISACODYL
• Active Ingredient Strength: 5 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 0536-3381-01

100 TABLET, DELAYED RELEASE in 1 BOX (0536-3381-01)

• Marketing Start Date: 2012-09-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0536-3381-10 [00536338110]

Enteric Coated Stimulant Laxative TABLET, DELAYED RELEASE

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-22
• Marketing End Date: 2018-01-01

NDC 0536-3381-01 [00536338101]

Enteric Coated Stimulant Laxative TABLET, DELAYED RELEASE

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-22
• Marketing End Date: 2018-01-01

Drug Details

Active Ingredients

Ingredient	Strength
BISACODYL	5 mg/1

OpenFDA Data

• SPL SET ID: c53bda6e-07f6-4871-b9af-5629d8844823
• Manufacturer:
  • Rugby Laboratories, Inc
• UNII:
  • 10X0709Y6I
• 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]
• UPC Code:
  • 0305363381101
• NUI Code:
  • N0000009371
  • N0000175812
  • N0000009871

NDC Crossover Matching brand name "Enteric Coated Stimulant Laxative" or generic name "Bisacodyl"

NDC	Brand Name	Generic Name
0536-3381	Enteric Coated Stimulant Laxative	Bisacodyl
70518-1616	Enteric Coated Stimulant Laxative	Enteric Coated Stimulant Laxative
33261-178	Enteric Coated Stimulant Laxative	Enteric Coated Stimulant Laxative
55700-512	Enteric Coated Stimulant Laxative	Enteric Coated Stimulant Laxative
63629-3049	Enteric Coated Stimulant Laxative	Enteric Coated Stimulant Laxative
0713-0109	BISAC-EVAC	Bisacodyl
0574-7050	Bisacodyl	bisacodyl
0904-6748	Bisacodyl	Bisacodyl
0904-7142	Bisacodyl	Bisacodyl
0904-7927	Bisacodyl	Bisacodyl
0536-1355	Biscolax	Bisacodyl
0904-5058	Biscolax Laxative	Bisacodyl
10237-906	Carters Little Pills	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
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