FAMOTIDINE

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeA02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7051838291
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-1)
ndc11
7051838293
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-3)
ndc11
7051838294
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-4)
ndc11
7051838295
30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3829-5)
ndc11
7051838296
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-6)
ndc11
7051838297
60 TABLET, FILM COATED in 1 BLISTER PACK (70518-3829-7)
ndc11
7051838298
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-8)
ndc11
7051838299
25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-9)

Annotations

UNII (FDA Substance ID)

5QZO15J2Z8

FAMOTIDINE

RxCUI 4278

Orange Book

A215630

ABAB

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": "70518-3829_4131acc0-1b7a-ff93-e063-6294a90a1c23",
  "productndc": "70518-3829",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215630",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Jan 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "FAMOTIDINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215630",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FAMOTIDINE",
  "start_marketing_date": "20230815",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BA03.

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