proctozone-b

Generic: bisacodyl

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name proctozone-b
Generic Name bisacodyl
Labeler rising pharma holdings, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

bisacodyl 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-337
Product ID 57237-337_ad7d1357-40a1-47d3-bb30-77aaf1547659
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M007.60
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

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 57237337
Hyphenated Format 57237-337

Supplemental Identifiers

RxCUI
198509
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 proctozone-b (source: ndc)
Generic Name bisacodyl (source: ndc)
Application Number M007.60 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (57237-337-03) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-337-51)
  • 3 BLISTER PACK in 1 CARTON (57237-337-21) / 4 SUPPOSITORY in 1 BLISTER PACK (57237-337-04)
source: ndc

Packages (2)

57237-337-03 6 BLISTER PACK in 1 CARTON (57237-337-03) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-337-51) 57237-337-21 3 BLISTER PACK in 1 CARTON (57237-337-21) / 4 SUPPOSITORY in 1 BLISTER PACK (57237-337-04)

Ingredients (1)

bisacodyl (10 mg/1)

Linked Drug Pages (1)

Proctozone-B ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "ad7d1357-40a1-47d3-bb30-77aaf1547659", "openfda": {"nui": ["N0000009371", "N0000175812", "N0000009871"], "unii": ["10X0709Y6I"], "rxcui": ["198509"], "spl_set_id": ["c53ed934-3846-4dc8-b97b-c84171c21ae1"], "pharm_class_pe": ["Increased Large Intestinal Motility [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Stimulant Laxative [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (57237-337-03)  / 5 SUPPOSITORY in 1 BLISTER PACK (57237-337-51)", "package_ndc": "57237-337-03", "marketing_start_date": "20250201"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (57237-337-21)  / 4 SUPPOSITORY in 1 BLISTER PACK (57237-337-04)", "package_ndc": "57237-337-21", "marketing_start_date": "20241201"}], "brand_name": "Proctozone-B", "product_id": "57237-337_ad7d1357-40a1-47d3-bb30-77aaf1547659", "dosage_form": "SUPPOSITORY", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Stimulant Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "57237-337", "generic_name": "Bisacodyl", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Proctozone-B", "active_ingredients": [{"name": "BISACODYL", "strength": "10 mg/1"}], "application_number": "M007.60", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}