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United States · US · US:63323-328_89168d2d-2dc0-3f50-e053-2a95a90a31be

Nafcillin

Orange BookUNIISPLATC J01CF06

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01CF06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332332820
    10 VIAL in 1 CARTON (63323-328-20) / 8 mL in 1 VIAL (63323-328-21)

Annotations

UNII (FDA Substance ID)
49G3001BCK
NAFCILLIN SODIUM
RxCUI 485026
Orange Book
A090002
APAP
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": "INTRAMUSCULAR; 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": "63323-328_89168d2d-2dc0-3f50-e053-2a95a90a31be",
  "productndc": "63323-328",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "090002",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jun 30, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jun 30, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAFCILLIN SODIUM",
  "proprietary_name": "Nafcillin",
  "active_ingred_unit": "g/8mL",
  "application_number": "ANDA090002",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NAFCILLIN SODIUM",
  "start_marketing_date": "20110630",
  "active_numerator_strength": "2"
}

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