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United States · US · US:71205-316_0f3c6538-799e-4147-9407-df86b8668c00

MEDIQUE Diamode

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7120531601
    1 TABLET in 1 PACKET (71205-316-01)
  • ndc11
    7120531606
    6 TABLET in 1 PACKET (71205-316-06)

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": {
    "f01adfcc-b32a-4a98-a4e7-2ce87b824b5a": {
      "match": "brand_token",
      "title": "MEDIQUE MEDIPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [SPORTPHARM LLC]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "71205-316_0f3c6538-799e-4147-9407-df86b8668c00",
  "productndc": "71205-316",
  "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": "MEDIQUE Diamode",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074091",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide Hydrochloride",
  "start_marketing_date": "20081230",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07DA03.

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