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United States · US · US:36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f

topcare lansoprazole

Orange BookUNIISPLATC A02BC03

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA02BC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3680039201
    1 BOTTLE in 1 CARTON (36800-392-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    3680039203
    3 BOTTLE in 1 CARTON (36800-392-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A202319
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0K5C5T2QPG",
    "rxcui": "17128",
    "inchikey": "MJIHNNLFOKEZEW-UHFFFAOYSA-N",
    "display_name": "LANSOPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f",
  "productndc": "36800-392",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202319",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "May 18, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "topcare lansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202319",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lansoprazole",
  "start_marketing_date": "20210729",
  "active_numerator_strength": "15"
}

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