prep non sterile

Generic: povidone-iodine

Labeler: changzhou maokang medical products co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name prep non sterile
Generic Name povidone-iodine
Labeler changzhou maokang medical products co., ltd
Dosage Form PATCH
Routes
TOPICAL
Active Ingredients

povidone-iodine 10 g/100g

Manufacturer
Changzhou Maokang Medical Products Co., Ltd

Identifiers & Regulatory

Product NDC 59050-455
Product ID 59050-455_0a3e519c-ecd6-d487-e063-6294a90a1f47
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

Pharmacologic Class

Established (EPC)
antiseptic [epc]
Chemical Structure
iodine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59050455
Hyphenated Format 59050-455

Supplemental Identifiers

UNII
85H0HZU99M
NUI
N0000175486 M0011640

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 prep non sterile (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 g/100g
source: ndc
Packaging
  • 5.5 g in 1 POUCH (59050-455-10)
source: ndc

Packages (1)

59050-455-10 5.5 g in 1 POUCH (59050-455-10)

Ingredients (1)

povidone-iodine (10 g/100g)

Linked Drug Pages (1)

Prep non sterile ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0a3e519c-ecd6-d487-e063-6294a90a1f47", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "spl_set_id": ["ecbe037b-77da-4ffc-8c60-e56f428766af"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Changzhou Maokang Medical Products Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5.5 g in 1 POUCH (59050-455-10)", "package_ndc": "59050-455-10", "marketing_start_date": "20180629"}], "brand_name": "Prep non sterile", "product_id": "59050-455_0a3e519c-ecd6-d487-e063-6294a90a1f47", "dosage_form": "PATCH", "product_ndc": "59050-455", "generic_name": "POVIDONE-IODINE", "labeler_name": "Changzhou Maokang Medical Products Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Prep non sterile", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "10 g/100g"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}