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United States · US · US:62207-774_44f2b222-ae43-eef4-e063-6394a90ab2b6

Ranitidine

Orange BookUNIISPLATC A02BA02

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

Identification

ManufacturerGranules India Ltd
CountryUS (United States)
ATC codeA02BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6220777436
    5 BAG in 1 CARTON (62207-774-36) / 10000 TABLET in 1 BAG
  • ndc11
    6220777441
    1 BOTTLE in 1 CARTON (62207-774-41) / 24 TABLET in 1 BOTTLE
  • ndc11
    6220777447
    1 BOTTLE in 1 CARTON (62207-774-47) / 500 TABLET in 1 BOTTLE
  • ndc11
    6220777458
    2 BLISTER PACK in 1 CARTON (62207-774-58) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
BK76465IHM
RANITIDINE HYDROCHLORIDE
RxCUI 203136
Orange Book
A210243
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": "62207-774_44f2b222-ae43-eef4-e063-6394a90ab2b6",
  "productndc": "62207-774",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210243",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Aug 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Aug 20, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "RANITIDINE HYDROCHLORIDE",
  "proprietary_name": "Ranitidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210243",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranitidine",
  "start_marketing_date": "20190626",
  "active_numerator_strength": "150"
}

Related drugs

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