povidone iodine prep

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
Generic Name povidone-iodine
Labeler jianerkang medical co., ltd
Dosage Form SWAB
Routes
TOPICAL
Active Ingredients

povidone-iodine 100 mg/g

Manufacturer
Jianerkang Medical Co., Ltd

Identifiers & Regulatory

Product NDC 34645-5506
Product ID 34645-5506_21da7d31-19ce-a5cb-e063-6294a90a63a4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2019-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 346455506
Hyphenated Format 34645-5506

Supplemental Identifiers

RxCUI
797730
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 (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 500 POUCH in 1 CARTON (34645-5506-0) / 1 POUCH in 1 POUCH / 2.5 g in 1 POUCH
  • 250 POUCH in 1 CARTON (34645-5506-1) / 3 POUCH in 1 POUCH / 13.5 g in 1 POUCH
source: ndc

Packages (2)

34645-5506-0 500 POUCH in 1 CARTON (34645-5506-0) / 1 POUCH in 1 POUCH / 2.5 g in 1 POUCH 34645-5506-1 250 POUCH in 1 CARTON (34645-5506-1) / 3 POUCH in 1 POUCH / 13.5 g in 1 POUCH

Ingredients (1)

povidone-iodine (100 mg/g)

Linked Drug Pages (1)

Povidone Iodine Prep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "21da7d31-19ce-a5cb-e063-6294a90a63a4", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["797730"], "spl_set_id": ["c1862529-e8d8-4440-a043-38c01079ee8a"], "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": "500 POUCH in 1 CARTON (34645-5506-0)  / 1 POUCH in 1 POUCH / 2.5 g in 1 POUCH", "package_ndc": "34645-5506-0", "marketing_start_date": "20190801"}, {"sample": false, "description": "250 POUCH in 1 CARTON (34645-5506-1)  / 3 POUCH in 1 POUCH / 13.5 g in 1 POUCH", "package_ndc": "34645-5506-1", "marketing_start_date": "20190801"}], "brand_name": "Povidone Iodine Prep", "product_id": "34645-5506_21da7d31-19ce-a5cb-e063-6294a90a63a4", "dosage_form": "SWAB", "product_ndc": "34645-5506", "generic_name": "POVIDONE-IODINE", "labeler_name": "Jianerkang Medical Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Povidone Iodine Prep", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "100 mg/g"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190801", "listing_expiration_date": "20261231"}