Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeA02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 14

ndc11
5860270509
3 BLISTER PACK in 1 CARTON (58602-705-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03)
ndc11
5860270512
4 BLISTER PACK in 1 CARTON (58602-705-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03)
ndc11
5860270514
1 BOTTLE in 1 CARTON (58602-705-14) / 50 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270515
1 BOTTLE in 1 CARTON (58602-705-15) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270519
1 BOTTLE in 1 CARTON (58602-705-19) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270532
1 BOTTLE in 1 CARTON (58602-705-32) / 180 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270534
1 BOTTLE in 1 CARTON (58602-705-34) / 200 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270539
1 BOTTLE in 1 CARTON (58602-705-39) / 365 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270540
1 BOTTLE in 1 CARTON (58602-705-40) / 500 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270541
1 BOTTLE in 1 CARTON (58602-705-41) / 1000 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270544
1 BOTTLE in 1 CARTON (58602-705-44) / 400 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270584
1 BOTTLE in 1 CARTON (58602-705-84) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270588
1 BOTTLE in 1 CARTON (58602-705-88) / 750 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860270593
90 TABLET, FILM COATED in 1 BOTTLE (58602-705-93)

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": "58602-705_83d5769e-ef9c-4ce5-afd5-a2dd7496274a",
  "productndc": "58602-705",
  "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": "10"
}

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