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United States · US · US:27241-109_d7fd99da-f17a-4124-9014-70bbe43d78f6

Ranitidine

Orange BookUNIISPLATC A02BA02

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

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeA02BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2724110906
    60 CAPSULE in 1 BOTTLE (27241-109-06)
  • ndc11
    2724110950
    500 CAPSULE in 1 BOTTLE (27241-109-50)

Annotations

UNII (FDA Substance ID)
BK76465IHM
RANITIDINE HYDROCHLORIDE
RxCUI 203136
Orange Book
A209859
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BK76465IHM",
    "rxcui": "203136",
    "inchikey": "GGWBHVILAJZWKJ-UHFFFAOYSA-N",
    "display_name": "RANITIDINE HYDROCHLORIDE",
    "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": "27241-109_d7fd99da-f17a-4124-9014-70bbe43d78f6",
  "productndc": "27241-109",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209859",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Sep 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 300MG BASE",
        "product_no": "002",
        "approval_date": "Sep 27, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RANITIDINE HYDROCHLORIDE",
  "proprietary_name": "Ranitidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209859",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranitidine",
  "start_marketing_date": "20180927",
  "active_numerator_strength": "150"
}

Related drugs

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