Private Label Distributor

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerUnifirst First Aid Corporation

CountryUS (United States)

ATC codeA07DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

77TI35393C

LOPERAMIDE HYDROCHLORIDE

RxCUI 82038

Orange Book

A074091

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "77TI35393C",
    "rxcui": "82038",
    "inchikey": "PGYPOBZJRVSMDS-UHFFFAOYSA-N",
    "display_name": "LOPERAMIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e74bddea-c1ac-4e4e-84bd-5a9defb85b2d": {
      "match": "brand_token",
      "title": "PRIVATE LABEL ANTIFUNGAL BARRIER CREAM (2% MICONAZOLE NITRATE CREAM) CREAM [SWISS-AMERICAN CDMO, LLC]",
      "spl_version": "4",
      "published_date": "2026-01-09"
    }
  },
  "productid": "47682-021_441e7620-28e5-8cc5-e063-6394a90a2a72",
  "productndc": "47682-021",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074091",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Dec 10, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Private Label Distributor",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074091",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide HCl 2 mg",
  "start_marketing_date": "20081230",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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