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United States · US · US:63323-812_c7907a70-1efa-46eb-b046-fcf043fdb413

Oxacillin

Orange BookUNIISPLATC J01CF04

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01CF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332381220
    10 VIAL, SINGLE-DOSE in 1 CARTON (63323-812-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-812-01)

Annotations

UNII (FDA Substance ID)
G0V6C994Q5
OXACILLIN SODIUM
RxCUI 9898
Orange Book
A206198
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G0V6C994Q5",
    "rxcui": "9898",
    "inchikey": "ZVIYWUUZWWBNMB-VICXVTCVSA-M",
    "display_name": "OXACILLIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "4972ec74-1d9a-de9b-e063-6394a90af786": {
      "match": "brand_token",
      "title": "OXACILLIN INJECTION, POWDER, FOR SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED]",
      "spl_version": "1",
      "published_date": "2026-01-29"
    }
  },
  "productid": "63323-812_c7907a70-1efa-46eb-b046-fcf043fdb413",
  "productndc": "63323-812",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "206198",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 20, 2020"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 20, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXACILLIN SODIUM",
  "proprietary_name": "Oxacillin",
  "active_ingred_unit": "g/20mL",
  "application_number": "ANDA206198",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxacillin",
  "start_marketing_date": "20201101",
  "active_numerator_strength": "2"
}

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