betadine

Generic: povidone-iodine

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name betadine
Generic Name povidone-iodine
Labeler alcon laboratories, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

povidone-iodine 5 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0411
Product ID 0065-0411_45bf2066-cfd2-48ef-acf9-b590c69b83d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018634
Listing Expiration 2026-12-31
Marketing Start 2000-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650411
Hyphenated Format 0065-0411

Supplemental Identifiers

RxCUI
312570 1149663
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 betadine (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number NDA018634 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0065-0411-30 1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE

Ingredients (1)

povidone-iodine (5 mg/mL)

Linked Drug Pages (1)

Betadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "45bf2066-cfd2-48ef-acf9-b590c69b83d8", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["312570", "1149663"], "spl_set_id": ["b026de1b-9949-4557-ac49-c7b0038c24cd"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0065-0411-30)  / 30 mL in 1 BOTTLE", "package_ndc": "0065-0411-30", "marketing_start_date": "20000401"}], "brand_name": "Betadine", "product_id": "0065-0411_45bf2066-cfd2-48ef-acf9-b590c69b83d8", "dosage_form": "SOLUTION", "product_ndc": "0065-0411", "generic_name": "povidone-iodine", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betadine", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "5 mg/mL"}], "application_number": "NDA018634", "marketing_category": "NDA", "marketing_start_date": "20000401", "listing_expiration_date": "20261231"}