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United States · US · US:50844-735_cb21f56f-f513-4fa1-817c-0e5c3ce660c5

Loperamide HCl

Orange BookUNIISPLATC A07DA03

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

Identification

ManufacturerL.N.K. International, Inc.
CountryUS (United States)
ATC codeA07DA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    5084473502
    2 BLISTER PACK in 1 CARTON (50844-735-02) / 6 TABLET in 1 BLISTER PACK
  • ndc11
    5084473508
    4 BLISTER PACK in 1 CARTON (50844-735-08) / 6 TABLET in 1 BLISTER PACK
  • ndc11
    5084473519
    2 BLISTER PACK in 1 CARTON (50844-735-19) / 4 TABLET in 1 BLISTER PACK
  • ndc11
    5084473524
    1 BLISTER PACK in 1 CARTON (50844-735-24) / 2 TABLET in 1 BLISTER PACK
  • ndc11
    5084473544
    3 BLISTER PACK in 1 CARTON (50844-735-44) / 6 TABLET in 1 BLISTER PACK
  • ndc11
    5084473545
    1 BLISTER PACK in 1 CARTON (50844-735-45) / 6 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
77TI35393C
LOPERAMIDE HYDROCHLORIDE
RxCUI 82038
Orange Book
A076497
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": {
    "0b1f8d41-51b3-4362-8de7-46bca5caff12": {
      "match": "brand_token",
      "title": "LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "6",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50844-735_cb21f56f-f513-4fa1-817c-0e5c3ce660c5",
  "productndc": "50844-735",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076497",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jun 10, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Loperamide HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide HCl",
  "start_marketing_date": "20050503",
  "active_numerator_strength": "2"
}

Related drugs

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