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United States · US · US:59651-565_faee6e2d-1b9c-4121-bc22-41313539b366

DICLOXACILLIN SODIUM

Orange BookUNIISPLATC J01CF01

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01CF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965156501
    100 CAPSULE in 1 BOTTLE (59651-565-01)

Annotations

UNII (FDA Substance ID)
4HZT2V9KX0
DICLOXACILLIN SODIUM
RxCUI 267257
Orange Book
A216845
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4HZT2V9KX0",
    "rxcui": "267257",
    "inchikey": "SIGZQNJITOWQEF-VICXVTCVSA-M",
    "display_name": "DICLOXACILLIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c17cd62d-ff5d-47ba-8673-3346c7f2365f": {
      "match": "brand_token",
      "title": "DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "22",
      "published_date": "2026-05-25"
    }
  },
  "productid": "59651-565_faee6e2d-1b9c-4121-bc22-41313539b366",
  "productndc": "59651-565",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216845",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Sep 23, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Sep 23, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOXACILLIN SODIUM",
  "proprietary_name": "DICLOXACILLIN SODIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216845",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DICLOXACILLIN SODIUM",
  "start_marketing_date": "20220923",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01CF01.

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