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United States · US · US:42507-699_3eb21c5b-67b7-4b0b-a643-d6e2d9190ef7

anti diarrheal anti gas

Orange BookSPLATC P03AX

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

Identification

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

Packs · 2

  • ndc11
    4250769953
    12 BLISTER PACK in 1 CARTON (42507-699-53) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    4250769962
    24 BLISTER PACK in 1 CARTON (42507-699-62) / 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": "42507-699_3eb21c5b-67b7-4b0b-a643-d6e2d9190ef7",
  "productndc": "42507-699",
  "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 anti gas",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA209837",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide hydrochloride, simethicone",
  "start_marketing_date": "20260225",
  "active_numerator_strength": "125; 2"
}

Related drugs

Other records sharing ATC code P03AX.

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