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United States · US · US:55111-396_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 · 10

  • ndc11
    5511139601
    1 BOTTLE in 1 CARTON (55111-396-01) / 100 TABLET in 1 BOTTLE
  • ndc11
    5511139608
    1 BLISTER PACK in 1 CARTON (55111-396-08) / 8 TABLET in 1 BLISTER PACK
  • ndc11
    5511139613
    1 BOTTLE in 1 CARTON (55111-396-13) / 130 TABLET in 1 BOTTLE
  • ndc11
    5511139616
    5 BLISTER PACK in 1 CARTON (55111-396-16) / 5 TABLET in 1 BLISTER PACK
  • ndc11
    5511139632
    1 BOTTLE in 1 CARTON (55111-396-32) / 170 TABLET in 1 BOTTLE
  • ndc11
    5511139635
    1 BOTTLE in 1 CARTON (55111-396-35) / 25 TABLET in 1 BOTTLE
  • ndc11
    5511139644
    2 BOTTLE in 1 CARTON (55111-396-44) / 100 TABLET in 1 BOTTLE
  • ndc11
    5511139650
    1 BOTTLE in 1 CARTON (55111-396-50) / 50 TABLET in 1 BOTTLE
  • ndc11
    5511139665
    1 BOTTLE in 1 CARTON (55111-396-65) / 65 TABLET in 1 BOTTLE
  • ndc11
    5511139690
    1 BOTTLE in 1 CARTON (55111-396-90) / 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": "55111-396_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82",
  "productndc": "55111-396",
  "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": "20"
}

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