povidone iodine prep solution sterile

Generic: povidone-iodine

Labeler: jianerkang medical co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name povidone iodine prep solution sterile
Generic Name povidone-iodine
Labeler jianerkang medical co., ltd
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 100 mg/mL

Manufacturer
Jianerkang Medical Co., Ltd

Identifiers & Regulatory

Product NDC 34645-0013
Product ID 34645-0013_085d0195-7031-e123-e063-6294a90ab344
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2021-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 346450013
Hyphenated Format 34645-0013

Supplemental Identifiers

RxCUI
312564
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 povidone iodine prep solution sterile (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 30 mL in 1 POUCH (34645-0013-1)
source: ndc

Packages (1)

34645-0013-1 30 mL in 1 POUCH (34645-0013-1)

Ingredients (1)

povidone-iodine (100 mg/mL)

Linked Drug Pages (1)

Povidone Iodine Prep Solution Sterile ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "085d0195-7031-e123-e063-6294a90ab344", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["312564"], "spl_set_id": ["95f8489e-05fa-4f0f-acd6-0c426009080e"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Jianerkang Medical Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 POUCH (34645-0013-1)", "package_ndc": "34645-0013-1", "marketing_start_date": "20210101"}], "brand_name": "Povidone Iodine Prep Solution Sterile", "product_id": "34645-0013_085d0195-7031-e123-e063-6294a90ab344", "dosage_form": "SOLUTION", "product_ndc": "34645-0013", "generic_name": "POVIDONE-IODINE", "labeler_name": "Jianerkang Medical Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone Iodine Prep Solution Sterile", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "100 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210101", "listing_expiration_date": "20261231"}