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United States · US · US:55111-131_210e3c0b-be93-aa50-550d-e383e7d5f19e

Ranitidine

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 · 10

  • ndc11
    5511113104
    1 BOTTLE in 1 CARTON (55111-131-04) / 120 TABLET in 1 BOTTLE
  • ndc11
    5511113114
    2 BLISTER PACK in 1 CARTON (55111-131-14) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5511113130
    1 BOTTLE in 1 CARTON (55111-131-30) / 30 TABLET in 1 BOTTLE
  • ndc11
    5511113137
    1 BOTTLE in 1 CARTON (55111-131-37) / 160 TABLET in 1 BOTTLE
  • ndc11
    5511113145
    1 BOTTLE in 1 CARTON (55111-131-45) / 45 TABLET in 1 BOTTLE
  • ndc11
    5511113160
    1 BOTTLE in 1 CARTON (55111-131-60) / 60 TABLET in 1 BOTTLE
  • ndc11
    5511113179
    1 BLISTER PACK in 1 CARTON (55111-131-79) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5511113180
    1 BOTTLE in 1 CARTON (55111-131-80) / 80 TABLET in 1 BOTTLE
  • ndc11
    5511113181
    3 BLISTER PACK in 1 CARTON (55111-131-81) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5511113190
    1 BOTTLE in 1 CARTON (55111-131-90) / 90 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
BK76465IHM
RANITIDINE HYDROCHLORIDE
RxCUI 203136
Orange Book
A075294
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": "55111-131_210e3c0b-be93-aa50-550d-e383e7d5f19e",
  "productndc": "55111-131",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075294",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Mar 28, 2000"
      }
    ],
    "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": "ANDA075294",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranitidine",
  "start_marketing_date": "20000301",
  "active_numerator_strength": "75"
}

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