stimulant laxative

Generic: bisacodyl

Labeler: time cap laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH NOT FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name stimulant laxative
Generic Name bisacodyl
Labeler time cap laboratories, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

bisacodyl 5 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-003
Product ID 49483-003_938bf8c5-6834-6362-e053-2995a90aa7e6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH NOT FINAL
Application Number part334
Listing Expiration 2026-12-31
Marketing Start 2014-04-01

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 49483003
Hyphenated Format 49483-003

Supplemental Identifiers

RxCUI
308753
UPC
0349483003529
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 stimulant laxative (source: ndc)
Generic Name bisacodyl (source: ndc)
Application Number part334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-003-00)
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-01)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10)
  • 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49483-003-52)
source: ndc

Packages (4)

49483-003-00 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-003-00) 49483-003-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-01) 49483-003-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10) 49483-003-52 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49483-003-52)

Ingredients (1)

bisacodyl (5 mg/1)

Linked Drug Pages (1)

STIMULANT LAXATIVE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "938bf8c5-6834-6362-e053-2995a90aa7e6", "openfda": {"nui": ["N0000009371", "N0000175812", "N0000009871"], "upc": ["0349483003529"], "unii": ["10X0709Y6I"], "rxcui": ["308753"], "spl_set_id": ["e0a9f8d9-660b-431c-8043-6d8ec81f98e5"], "pharm_class_pe": ["Increased Large Intestinal Motility [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Stimulant Laxative [EPC]"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-003-00)", "package_ndc": "49483-003-00", "marketing_start_date": "20181207"}, {"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-01)", "package_ndc": "49483-003-01", "marketing_start_date": "20181207"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10)", "package_ndc": "49483-003-10", "marketing_start_date": "20181207"}, {"sample": false, "description": "25 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49483-003-52)", "package_ndc": "49483-003-52", "marketing_start_date": "20181207"}], "brand_name": "STIMULANT LAXATIVE", "product_id": "49483-003_938bf8c5-6834-6362-e053-2995a90aa7e6", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Stimulant Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "49483-003", "generic_name": "BISACODYL", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "STIMULANT LAXATIVE", "active_ingredients": [{"name": "BISACODYL", "strength": "5 mg/1"}], "application_number": "part334", "marketing_category": "OTC MONOGRAPH NOT FINAL", "marketing_start_date": "20140401", "listing_expiration_date": "20261231"}