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United States · US · US:58602-706_4329025b-5cdd-4287-955f-028e6aca198c

Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 20

  • ndc11
    5860270614
    1 BOTTLE in 1 CARTON (58602-706-14) / 50 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270615
    2 BLISTER PACK in 1 CARTON (58602-706-15) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5860270616
    1 BOTTLE in 1 CARTON (58602-706-16) / 65 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270618
    1 BOTTLE in 1 CARTON (58602-706-18) / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270619
    1 BOTTLE in 1 CARTON (58602-706-19) / 90 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270621
    1 BOTTLE in 1 CARTON (58602-706-21) / 100 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270634
    1 BOTTLE in 1 CARTON (58602-706-34) / 200 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270639
    1 BOTTLE in 1 CARTON (58602-706-39) / 365 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270640
    1 BOTTLE in 1 CARTON (58602-706-40) / 500 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270641
    1000 TABLET, FILM COATED in 1 BOTTLE (58602-706-41)
  • ndc11
    5860270644
    1 BOTTLE in 1 CARTON (58602-706-44) / 400 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270647
    1 BOTTLE in 1 CARTON (58602-706-47) / 75 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270650
    1 BOTTLE in 1 CARTON (58602-706-50) / 85 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270653
    1 BOTTLE in 1 CARTON (58602-706-53) / 25 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270654
    1 BOTTLE in 1 CARTON (58602-706-54) / 70 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270656
    1 BOTTLE in 1 CARTON (58602-706-56) / 35 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860270662
    5 BLISTER PACK in 1 CARTON (58602-706-62) / 5 TABLET, FILM COATED in 1 BLISTER PACK (58602-706-60)
  • ndc11
    5860270679
    1 BLISTER PACK in 1 CARTON (58602-706-79) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5860270688
    750 TABLET, FILM COATED in 1 BOTTLE (58602-706-88)
  • ndc11
    5860270694
    100 TABLET, FILM COATED in 1 BOTTLE (58602-706-94)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A206531
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": "58602-706_4329025b-5cdd-4287-955f-028e6aca198c",
  "productndc": "58602-706",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206531",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Apr 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20160426",
  "active_numerator_strength": "20"
}

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