simpex bisacodyl laxative (76457-003)

Drug Facts

Product Profile

Brand Name simpex bisacodyl laxative

Generic Name bisacodyl

Labeler simpex pharma pvt. ltd

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

bisacodyl 5 mg/1

Manufacturer

Simpex Pharma Pvt. Ltd

Identifiers & Regulatory

Product NDC 76457-003

Product ID 76457-003_0b586450-2c14-70e7-e063-6394a90a5f33

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M007

Listing Expiration 2026-12-31

Marketing Start 2018-02-09

Pharmacologic Class

Established (EPC)

stimulant laxative [epc]

Physiologic Effect

increased large intestinal motility [pe] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76457003

Hyphenated Format 76457-003

Supplemental Identifiers

RxCUI

308753

UPC

8901252955389

UNII

10X0709Y6I

NUI

N0000009371 N0000175812 N0000009871

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name simpex bisacodyl laxative (source: ndc)

Generic Name bisacodyl (source: ndc)

Application Number M007 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1

source: ndc

Packaging

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

source: ndc

Packages (1)

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

Ingredients (1)

bisacodyl (5 mg/1)

Linked Drug Pages (1)

SIMPEX Bisacodyl laxative ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "0b586450-2c14-70e7-e063-6394a90a5f33", "openfda": {"nui": ["N0000009371", "N0000175812", "N0000009871"], "upc": ["8901252955389"], "unii": ["10X0709Y6I"], "rxcui": ["308753"], "spl_set_id": ["5114ed64-4fec-401b-8a91-8df3e42b10b1"], "pharm_class_pe": ["Increased Large Intestinal Motility [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Stimulant Laxative [EPC]"], "manufacturer_name": ["Simpex Pharma Pvt. Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 CARTON (76457-003-00)", "package_ndc": "76457-003-00", "marketing_start_date": "20180209"}], "brand_name": "SIMPEX Bisacodyl laxative", "product_id": "76457-003_0b586450-2c14-70e7-e063-6394a90a5f33", "dosage_form": "TABLET, COATED", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Stimulant Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "76457-003", "generic_name": "BISACODYL", "labeler_name": "Simpex Pharma Pvt. Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMPEX Bisacodyl laxative", "active_ingredients": [{"name": "BISACODYL", "strength": "5 mg/1"}], "application_number": "M007", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180209", "listing_expiration_date": "20261231"}