Ibuprofen and famotidine

Orange BookUNIISPLATC A02BA

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeA02BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642089101
100 TABLET, FILM COATED in 1 BOTTLE (76420-891-01)
ndc11
7642089105
500 TABLET, FILM COATED in 1 BOTTLE (76420-891-05)
ndc11
7642089106
6 BLISTER PACK in 1 CARTON (76420-891-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7642089130
30 TABLET, FILM COATED in 1 BOTTLE (76420-891-30)
ndc11
7642089160
60 TABLET, FILM COATED in 1 BOTTLE (76420-891-60)
ndc11
7642089190
90 TABLET, FILM COATED in 1 BOTTLE (76420-891-90)

Annotations

UNII (FDA Substance ID)

5QZO15J2Z8

FAMOTIDINE

RxCUI 4278

Orange Book

A211890

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": {
    "aeee629b-255c-40d8-8e95-779aec00f723": {
      "match": "brand_token",
      "title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "76420-891_2abbd7c9-640f-d0cb-e063-6294a90a23f0",
  "productndc": "76420-891",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211890",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "26.6MG;800MG",
        "product_no": "001",
        "approval_date": "Aug 3, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE; IBUPROFEN",
  "proprietary_name": "Ibuprofen and famotidine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211890",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and famotidine",
  "start_marketing_date": "20210804",
  "active_numerator_strength": "26.6; 800"
}

Related drugs

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