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United States · US · US:0338-1019_ad3cc424-4e9f-49e8-b72b-6969ae6b16b8

NAFCILLIN

Orange BookUNIISPLATC J01CF06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeJ01CF06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338101948
    100 mL in 1 BAG (0338-1019-48)

Annotations

UNII (FDA Substance ID)
49G3001BCK
NAFCILLIN SODIUM
RxCUI 485026
Orange Book
N050655
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "49G3001BCK",
    "rxcui": "485026",
    "inchikey": "OCXSDHJRMYFTMA-KMFBOIRUSA-M",
    "display_name": "NAFCILLIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "4b3b8e52-df96-4886-e063-6294a90ac63f": {
      "match": "brand_token",
      "title": "NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED]",
      "spl_version": "2",
      "published_date": "2026-04-06"
    }
  },
  "productid": "0338-1019_ad3cc424-4e9f-49e8-b72b-6969ae6b16b8",
  "productndc": "0338-1019",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "050655",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE/ML",
        "product_no": "001",
        "approval_date": "Oct 31, 1989"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2GM BASE/100ML",
        "product_no": "002",
        "approval_date": "Oct 31, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAFCILLIN SODIUM",
  "proprietary_name": "NAFCILLIN",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA050655",
  "marketing_category": "NDA",
  "nonproprietary_name": "NAFCILLIN",
  "start_marketing_date": "19891031",
  "active_numerator_strength": "2"
}

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