BSS PLUS

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAlcon Laboratories, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0065080094
1 KIT in 1 PACKAGE (0065-0800-94) * 480 mL in 1 BAG * 20 mL in 1 VIAL, GLASS

Annotations

Orange Book

N018469

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea": {
      "match": "brand_token",
      "title": "BSS (BALANCED SALT SOLUTION) SOLUTION [ALCON LABORATORIES, INC.]",
      "spl_version": "15",
      "published_date": "2024-01-26"
    }
  },
  "productid": "0065-0800_9bfcc79c-fa98-4800-b6ca-064544e74f2d",
  "productndc": "0065-0800",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "018469",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "BSS PLUS",
  "active_ingred_unit": null,
  "application_number": "NDA018469",
  "marketing_category": "NDA",
  "nonproprietary_name": "balanced salt solution enriched with bicarbonate, dextrose, and glutathione",
  "start_marketing_date": "20130620",
  "active_numerator_strength": null
}

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