NDC 76457-003

SIMPEX Bisacodyl laxative

Bisacodyl

SIMPEX Bisacodyl laxative is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Simpex Pharma Pvt. Ltd. The primary component is Bisacodyl.

• Product ID: 76457-003_7d86fea4-e6fd-fa26-e053-2a91aa0a4e5f
• NDC: 76457-003
• Product Type: Human Otc Drug
• Proprietary Name: SIMPEX Bisacodyl laxative
• Generic Name: Bisacodyl
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-02-09
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part334
• Labeler Name: Simpex Pharma Pvt. Ltd
• Substance Name: BISACODYL
• Active Ingredient Strength: 5 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 76457-003-00

100 TABLET, COATED in 1 CARTON (76457-003-00)

• Marketing Start Date: 2018-02-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76457-003-00 [76457000300]

SIMPEX Bisacodyl laxative TABLET, COATED

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-02-09

Drug Details

Active Ingredients

Ingredient	Strength
BISACODYL	5 mg/1

OpenFDA Data

• SPL SET ID: 5114ed64-4fec-401b-8a91-8df3e42b10b1
• Manufacturer:
  • Simpex Pharma Pvt. Ltd
• 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:
  • 8901252955389
• NUI Code:
  • N0000009371
  • N0000175812
  • N0000009871

NDC Crossover Matching brand name "SIMPEX Bisacodyl laxative" or generic name "Bisacodyl"

NDC	Brand Name	Generic Name
76457-003	SIMPEX Bisacodyl laxative	SIMPEX Bisacodyl 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
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