Sertraline

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

Product NDC 70518-0153
Package NDC 70518-0153-0
Application number ANDA077670
SPL ID 4cd7bcf3-e201-e857-e063-6294a90a929b
SPL set ID 84aba223-04ae-479c-b5dd-e04fab45045d
UNII UTI8907Y6X
RxCUI 312941

What the source publishes

Labeler: REMEDYREPACK INC.
Active ingredients: Sertraline
Form: TABLET, FILM COATED
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:70518-0153_4cd7bcf3-e201-e857-e063-6294a90a929b

{
  "name": "Sertraline",
  "splId": "4cd7bcf3-e201-e857-e063-6294a90a929b",
  "labels": [
    {
      "setId": "84aba223-04ae-479c-b5dd-e04fab45045d",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84aba223-04ae-479c-b5dd-e04fab45045d",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=84aba223-04ae-479c-b5dd-e04fab45045d"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "REMEDYREPACK INC.",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0153-0)",
      "package_ndc": "70518-0153-0",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20170102"
    }
  ],
  "productId": "70518-0153_4cd7bcf3-e201-e857-e063-6294a90a929b",
  "useDomain": "unknown",
  "dosageForm": "TABLET, FILM COATED",
  "productNdc": "70518-0153",
  "deaSchedule": null,
  "genericName": "Sertraline",
  "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": "SERTRALINE HYDROCHLORIDE",
      "strength": "50 mg/1"
    }
  ],
  "applicationNumber": "ANDA077670",
  "marketingCategory": "ANDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20170102",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "unii": [
      "UTI8907Y6X"
    ],
    "rxcui": [
      "312941"
    ],
    "spl_set_id": [
      "84aba223-04ae-479c-b5dd-e04fab45045d"
    ],
    "manufacturer_name": [
      "REMEDYREPACK INC."
    ]
  },
  "listingExpirationDate": "20271231"
}

NDC Directory

U.S. Food and Drug Administration / openFDA

Retrieved: November 12, 2026
Licence: CC0 1.0
Source id: us.fda.ndc

Official source

What this source does not establish

Complete published endpoint, not a claim that FDA lists every medicine used in the US.
NDC listing, marketing category and application-number assertions are not proof of approval.
Tentative approval, discontinued products and historical submissions remain distinct.
Official document links only; linked documents have not been relicensed or mirrored.
No state restrictions, individual eligibility, or prescribing recommendations inferred.
UNII and RxNorm identifiers are source-asserted openFDA harmonization at record scope; arrays do not pair identifiers to individual products or ingredients, and are not GSID/PhPID or substitution evidence.

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