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United States · US · US:55111-118_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82

Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerDr.Reddys Laboratories Limited
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 11

  • ndc11
    5511111804
    1 BOTTLE in 1 CARTON (55111-118-04) / 120 TABLET in 1 BOTTLE
  • ndc11
    5511111812
    1 BLISTER PACK in 1 CARTON (55111-118-12) / 12 TABLET in 1 BLISTER PACK
  • ndc11
    5511111818
    1 BOTTLE in 1 CARTON (55111-118-18) / 180 TABLET in 1 BOTTLE
  • ndc11
    5511111824
    4 BLISTER PACK in 1 CARTON (55111-118-24) / 6 TABLET in 1 BLISTER PACK
  • ndc11
    5511111830
    1 BOTTLE in 1 CARTON (55111-118-30) / 30 TABLET in 1 BOTTLE
  • ndc11
    5511111835
    3 BLISTER PACK in 1 CARTON (55111-118-35) / 6 TABLET in 1 BLISTER PACK
  • ndc11
    5511111840
    1 BOTTLE in 1 CARTON (55111-118-40) / 40 TABLET in 1 BOTTLE
  • ndc11
    5511111860
    1 BOTTLE in 1 CARTON (55111-118-60) / 60 TABLET in 1 BOTTLE
  • ndc11
    5511111879
    1 BLISTER PACK in 1 CARTON (55111-118-79) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5511111881
    3 BLISTER PACK in 1 CARTON (55111-118-81) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5511111890
    1 BOTTLE in 1 CARTON (55111-118-90) / 90 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A077367
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5QZO15J2Z8",
    "rxcui": "4278",
    "inchikey": "XUFQPHANEAPEMJ-UHFFFAOYSA-N",
    "display_name": "FAMOTIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e53928f3-5181-490b-acfb-be8d4cea60a9": {
      "match": "brand_token",
      "title": "FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "55111-118_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82",
  "productndc": "55111-118",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077367",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Sep 25, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 17, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077367",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20060930",
  "active_numerator_strength": "10"
}

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