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United States · US · US:41250-375_ea6fe67a-827f-48ec-a1f7-9c619b04d8c4

anti diarrheal plus anti gas

Orange BookSPLATC P03AX

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

Identification

ManufacturerMeijer Distribution Inc
CountryUS (United States)
ATC codeP03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4125037562
    24 BLISTER PACK in 1 CARTON (41250-375-62) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    4125037589
    18 BLISTER PACK in 1 CARTON (41250-375-89) / 1 TABLET in 1 BLISTER PACK

Annotations

Orange Book
A209837
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "dd993f38-a31f-4739-9496-e14186a89053": {
      "match": "brand_token",
      "title": "ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]",
      "spl_version": "6",
      "published_date": "2026-05-21"
    }
  },
  "productid": "41250-375_ea6fe67a-827f-48ec-a1f7-9c619b04d8c4",
  "productndc": "41250-375",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209837",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG;125MG",
        "product_no": "001",
        "approval_date": "Sep 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "anti diarrheal plus anti gas",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA209837",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide hydrochloride, simethicone",
  "start_marketing_date": "20181016",
  "active_numerator_strength": "125; 2"
}

Related drugs

Other records sharing ATC code P03AX.

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