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United States · US · US:21130-027_01af6236-f4ba-5999-e063-6394a90a3806

Maximum Strength Acid Controller

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerBETTER LIVING BRANDS LLC.
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2113002705
    1 BOTTLE in 1 CARTON (21130-027-05) / 50 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A217543
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": {
    "350764de-7801-b24e-e063-6394a90ab3c3": {
      "match": "brand_token",
      "title": "MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, GUAIFENESIN) TABLET, FILM COATED [RECKITT BENCKISER LLC]",
      "spl_version": "2",
      "published_date": "2026-05-15"
    }
  },
  "productid": "21130-027_01af6236-f4ba-5999-e063-6394a90a3806",
  "productndc": "21130-027",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217543",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Mar 8, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Maximum Strength Acid Controller",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217543",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20230623",
  "active_numerator_strength": "20"
}

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