GERI-LANTA ANTACID ANTIGAS

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

  • Product NDC 68788-8169
  • Package NDC 68788-8169-3
  • Application number M001
  • SPL ID bc94de15-7aff-4f04-9c7b-dfd090604fa1
  • SPL set ID 27848ae0-3b2f-4bfe-8856-4b8de419091e
  • UNII 5QB0T2IUN0
  • UNII NBZ3QY004S
  • UNII 92RU3N3Y1O
  • RxCUI 307746

What the source publishes

Labeler
Preferred Pharmaceuticals Inc.
Active ingredients
aluminum hydroxide, magnesium hydroxide, dimethicone
Form
SUSPENSION
Routes
ORAL
Administrative status
present-in-source-snapshot
Marketing status
OTC MONOGRAPH DRUG
Product type
HUMAN OTC DRUG
Prescription
Non-prescription

Names this record is found by

Complete source data
us:fda:ndc:68788-8169_bc94de15-7aff-4f04-9c7b-dfd090604fa1
{
  "name": "GERI-LANTA ANTACID ANTIGAS",
  "splId": "bc94de15-7aff-4f04-9c7b-dfd090604fa1",
  "labels": [
    {
      "setId": "27848ae0-3b2f-4bfe-8856-4b8de419091e",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27848ae0-3b2f-4bfe-8856-4b8de419091e",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=27848ae0-3b2f-4bfe-8856-4b8de419091e"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "Preferred Pharmaceuticals Inc.",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "355 mL in 1 BOTTLE (68788-8169-3)",
      "package_ndc": "68788-8169-3",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20220711"
    }
  ],
  "productId": "68788-8169_bc94de15-7aff-4f04-9c7b-dfd090604fa1",
  "useDomain": "unknown",
  "dosageForm": "SUSPENSION",
  "productNdc": "68788-8169",
  "deaSchedule": null,
  "genericName": "aluminum hydroxide, magnesium hydroxide, dimethicone",
  "productType": "HUMAN OTC 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": "ALUMINUM HYDROXIDE",
      "strength": "200 mg/5mL"
    },
    {
      "name": "MAGNESIUM HYDROXIDE",
      "strength": "200 mg/5mL"
    },
    {
      "name": "DIMETHICONE, UNSPECIFIED",
      "strength": "20 mg/5mL"
    }
  ],
  "applicationNumber": "M001",
  "marketingCategory": "OTC MONOGRAPH DRUG",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20220711",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "non-prescription",
  "harmonizedIdentifiers": {
    "unii": [
      "5QB0T2IUN0",
      "NBZ3QY004S",
      "92RU3N3Y1O"
    ],
    "rxcui": [
      "307746"
    ],
    "spl_set_id": [
      "27848ae0-3b2f-4bfe-8856-4b8de419091e"
    ],
    "manufacturer_name": [
      "Preferred Pharmaceuticals Inc."
    ]
  },
  "listingExpirationDate": "20271231"
}

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