Paricalcitol

NDC product · U.S. Food and Drug Administration (openFDA) · United States

  • Product NDC 49483-688
  • Package NDC 49483-688-03
  • Application number ANDA204948
  • SPL ID eed565d0-059d-eef6-e053-2a95a90ac962
  • SPL set ID f593b575-7537-4531-87fc-c1b0814fd018
  • UNII 6702D36OG5
  • RxCUI 577315
  • RxCUI 577317
  • RxCUI 577324

What the source publishes

Labeler
TIME CAP LABORATORIES, INC
Active ingredients
Paricalcitol
Form
CAPSULE, LIQUID FILLED
Routes
ORAL
Administrative status
present-in-source-snapshot
Marketing status
ANDA
Product type
HUMAN PRESCRIPTION DRUG
Prescription
Prescription or restricted

Names this record is found by

Complete source data
us:fda:ndc:49483-688_eed565d0-059d-eef6-e053-2a95a90ac962
{
  "name": "Paricalcitol",
  "splId": "eed565d0-059d-eef6-e053-2a95a90ac962",
  "labels": [
    {
      "setId": "f593b575-7537-4531-87fc-c1b0814fd018",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f593b575-7537-4531-87fc-c1b0814fd018",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=f593b575-7537-4531-87fc-c1b0814fd018"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "TIME CAP LABORATORIES, INC",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-688-03)",
      "package_ndc": "49483-688-03",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20170103"
    }
  ],
  "productId": "49483-688_eed565d0-059d-eef6-e053-2a95a90ac962",
  "useDomain": "unknown",
  "dosageForm": "CAPSULE, LIQUID FILLED",
  "productNdc": "49483-688",
  "deaSchedule": null,
  "genericName": "Paricalcitol",
  "productType": "HUMAN PRESCRIPTION DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "PARICALCITOL",
      "strength": "2 ug/1"
    }
  ],
  "applicationNumber": "ANDA204948",
  "marketingCategory": "ANDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20151230",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "nui": [
      "M0007651",
      "N0000175907",
      "N0000175849"
    ],
    "upc": [
      "0349483687033",
      "0349483688030",
      "0349483689037"
    ],
    "unii": [
      "6702D36OG5"
    ],
    "rxcui": [
      "577315",
      "577317",
      "577324"
    ],
    "spl_set_id": [
      "f593b575-7537-4531-87fc-c1b0814fd018"
    ],
    "pharm_class_cs": [
      "Ergocalciferols [CS]"
    ],
    "pharm_class_epc": [
      "Vitamin D2 Analog [EPC]",
      "Vitamin D Analog [EPC]"
    ],
    "manufacturer_name": [
      "TIME CAP LABORATORIES, INC"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20261231"
}

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