Ranitidine

Orange BookUNIISPLATC A02BA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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 · 14

ndc11
5511140402
1 BOTTLE in 1 CARTON (55111-404-02) / 200 TABLET, COATED in 1 BOTTLE
ndc11
5511140417
1 BLISTER PACK in 1 CARTON (55111-404-17) / 8 TABLET, COATED in 1 BLISTER PACK
ndc11
5511140424
3 BLISTER PACK in 1 CARTON (55111-404-24) / 8 TABLET, COATED in 1 BLISTER PACK
ndc11
5511140432
1 BOTTLE in 1 CARTON (55111-404-32) / 32 TABLET, COATED in 1 BOTTLE
ndc11
5511140434
1 BOTTLE in 1 CARTON (55111-404-34) / 24 TABLET, COATED in 1 BOTTLE
ndc11
5511140436
1 BOTTLE in 1 CARTON (55111-404-36) / 36 TABLET, COATED in 1 BOTTLE
ndc11
5511140438
4 BLISTER PACK in 1 CARTON (55111-404-38) / 8 TABLET, COATED in 1 BLISTER PACK
ndc11
5511140440
1 BOTTLE in 1 BOTTLE (55111-404-40) / 40 TABLET, COATED in 1 BOTTLE
ndc11
5511140450
1 BOTTLE in 1 CARTON (55111-404-50) / 50 TABLET, COATED in 1 BOTTLE
ndc11
5511140455
2 BOTTLE in 1 CARTON (55111-404-55) / 65 TABLET, COATED in 1 BOTTLE
ndc11
5511140461
1 BOTTLE in 1 CARTON (55111-404-61) / 65 TABLET, COATED in 1 BOTTLE
ndc11
5511140462
1 BOTTLE in 1 CARTON (55111-404-62) / 95 TABLET, COATED in 1 BOTTLE
ndc11
5511140465
1 BOTTLE in 1 CARTON (55111-404-65) / 220 TABLET, COATED in 1 BOTTLE
ndc11
5511140490
2 BOTTLE in 1 CARTON (55111-404-90) / 95 TABLET, COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

BK76465IHM

RANITIDINE HYDROCHLORIDE

RxCUI 203136

Orange Book

A078192

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": "55111-404_c47f1d10-c4d9-5df4-84e8-55956b47568b",
  "productndc": "55111-404",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "078192",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Aug 31, 2007"
      }
    ],
    "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": "ANDA078192",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranitidine",
  "start_marketing_date": "20091202",
  "active_numerator_strength": "150"
}

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