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United States · US · US:0121-0727_d56a22ea-5dab-e98a-e053-2a95a90a34c4

Ranitidine

Orange BookUNIISPLATC A02BA02

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

Identification

ManufacturerPharmaceutical Associates, Inc.
CountryUS (United States)
ATC codeA02BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0121072716
    473 mL in 1 BOTTLE (0121-0727-16)

Annotations

UNII (FDA Substance ID)
884KT10YB7
RANITIDINE
RxCUI 9143
Orange Book
A077405
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "884KT10YB7",
    "rxcui": "9143",
    "inchikey": "VMXUWOKSQNHOCA-UHFFFAOYSA-N",
    "display_name": "RANITIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b38a3332-5c54-453f-aeb7-070f830955c2": {
      "match": "brand_token",
      "title": "RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "21",
      "published_date": "2026-05-04"
    }
  },
  "productid": "0121-0727_d56a22ea-5dab-e98a-e053-2a95a90a34c4",
  "productndc": "0121-0727",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "077405",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 15MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 21, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RANITIDINE",
  "proprietary_name": "Ranitidine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA077405",
  "marketing_category": "ANDA",
  "nonproprietary_name": "RANITIDINE",
  "start_marketing_date": "20101101",
  "active_numerator_strength": "15"
}

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