pvp-i pouch foil-foil

Generic: povidone-iodine

Labeler: dukal llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pvp-i pouch foil-foil
Generic Name povidone-iodine
Labeler dukal llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 1 g/100mL

Manufacturer
Dukal LLC

Identifiers & Regulatory

Product NDC 65517-0035
Product ID 65517-0035_43f8ee7b-b7fb-b4ce-e063-6294a90a2500
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2018-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 655170035
Hyphenated Format 65517-0035

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 pvp-i pouch foil-foil (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 500 POUCH in 1 CASE (65517-0035-1) / 22 mL in 1 POUCH
  • 250 POUCH in 1 CASE (65517-0035-2) / 29.57 mL in 1 POUCH
source: ndc

Packages (2)

65517-0035-1 500 POUCH in 1 CASE (65517-0035-1) / 22 mL in 1 POUCH 65517-0035-2 250 POUCH in 1 CASE (65517-0035-2) / 29.57 mL in 1 POUCH

Ingredients (1)

povidone-iodine (1 g/100mL)

Linked Drug Pages (1)

PVP-I Pouch foil-foil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "43f8ee7b-b7fb-b4ce-e063-6294a90a2500", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["312564"], "spl_set_id": ["45aefabf-5283-411a-b509-749977635938"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Dukal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 POUCH in 1 CASE (65517-0035-1)  / 22 mL in 1 POUCH", "package_ndc": "65517-0035-1", "marketing_start_date": "20180131"}, {"sample": false, "description": "250 POUCH in 1 CASE (65517-0035-2)  / 29.57 mL in 1 POUCH", "package_ndc": "65517-0035-2", "marketing_start_date": "20181109"}], "brand_name": "PVP-I Pouch foil-foil", "product_id": "65517-0035_43f8ee7b-b7fb-b4ce-e063-6294a90a2500", "dosage_form": "SOLUTION", "product_ndc": "65517-0035", "generic_name": "Povidone-iodine", "labeler_name": "Dukal LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PVP-I Pouch foil-foil", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "1 g/100mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180131", "listing_expiration_date": "20261231"}