betadine solution

Generic: povidone-iodine

Labeler: atlantis consumer healthcare, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name betadine solution
Generic Name povidone-iodine
Labeler atlantis consumer healthcare, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

povidone-iodine 10 mg/mL

Manufacturer
Atlantis Consumer Healthcare, Inc.

Identifiers & Regulatory

Product NDC 67618-150
Product ID 67618-150_81830efd-5944-490f-86cf-90add1fdd2e3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 1980-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67618150
Hyphenated Format 67618-150

Supplemental Identifiers

RxCUI
211108 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 betadine solution (source: ndc)
Generic Name povidone-iodine (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 3780 mL in 1 BOTTLE (67618-150-01)
  • 118 mL in 1 BOTTLE (67618-150-04)
  • 14.8 mL in 1 BOTTLE (67618-150-05)
  • 237 mL in 1 BOTTLE (67618-150-09)
  • 473 mL in 1 BOTTLE (67618-150-17)
source: ndc

Packages (5)

67618-150-01 3780 mL in 1 BOTTLE (67618-150-01) 67618-150-04 118 mL in 1 BOTTLE (67618-150-04) 67618-150-05 14.8 mL in 1 BOTTLE (67618-150-05) 67618-150-09 237 mL in 1 BOTTLE (67618-150-09) 67618-150-17 473 mL in 1 BOTTLE (67618-150-17)

Ingredients (1)

povidone-iodine (10 mg/mL)

Linked Drug Pages (2)

Betadine Solution ndc-match (0.9) Betadine Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "81830efd-5944-490f-86cf-90add1fdd2e3", "openfda": {"nui": ["N0000175486", "M0011640"], "unii": ["85H0HZU99M"], "rxcui": ["211108", "312564"], "spl_set_id": ["41891599-420e-48d2-8e31-d28a2209e383"], "pharm_class_cs": ["Iodine [CS]"], "pharm_class_epc": ["Antiseptic [EPC]"], "manufacturer_name": ["Atlantis Consumer Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3780 mL in 1 BOTTLE (67618-150-01)", "package_ndc": "67618-150-01", "marketing_start_date": "19800601"}, {"sample": false, "description": "118 mL in 1 BOTTLE (67618-150-04)", "package_ndc": "67618-150-04", "marketing_start_date": "19800601"}, {"sample": false, "description": "14.8 mL in 1 BOTTLE (67618-150-05)", "package_ndc": "67618-150-05", "marketing_start_date": "19800601"}, {"sample": false, "description": "237 mL in 1 BOTTLE (67618-150-09)", "package_ndc": "67618-150-09", "marketing_start_date": "19800601"}, {"sample": false, "description": "473 mL in 1 BOTTLE (67618-150-17)", "package_ndc": "67618-150-17", "marketing_start_date": "19800601"}], "brand_name": "Betadine Solution", "product_id": "67618-150_81830efd-5944-490f-86cf-90add1fdd2e3", "dosage_form": "SOLUTION", "product_ndc": "67618-150", "generic_name": "POVIDONE-IODINE", "labeler_name": "Atlantis Consumer Healthcare, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Betadine", "brand_name_suffix": "Solution", "active_ingredients": [{"name": "POVIDONE-IODINE", "strength": "10 mg/mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19800601", "listing_expiration_date": "20261231"}