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United States · US · US:55111-130_9741e6f4-a2dc-7543-1138-da97eafe11bd

Ranitidine Hydrochloride

Orange BookUNIISPLATC A02BA02

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

Identification

ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeA02BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5511113001
    100 CAPSULE in 1 BOTTLE (55111-130-01)
  • ndc11
    5511113030
    30 CAPSULE in 1 BOTTLE (55111-130-30)

Annotations

UNII (FDA Substance ID)
BK76465IHM
RANITIDINE HYDROCHLORIDE
RxCUI 203136
Orange Book
A075742
ABAB
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": "55111-130_9741e6f4-a2dc-7543-1138-da97eafe11bd",
  "productndc": "55111-130",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075742",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Nov 29, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "002",
        "approval_date": "Nov 29, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RANITIDINE HYDROCHLORIDE",
  "proprietary_name": "Ranitidine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075742",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranitidine Hydrochloride",
  "start_marketing_date": "20010401",
  "active_numerator_strength": "300"
}

Related drugs

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