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United States · US · US:37808-714_09c4848d-0d0f-4400-97a9-8ae26913e540

anti diarrheal anti gas

Orange BookSPLATC P03AX

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeP03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3780871453
    12 BLISTER PACK in 1 CARTON (37808-714-53) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    3780871462
    24 BLISTER PACK in 1 CARTON (37808-714-62) / 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": "37808-714_09c4848d-0d0f-4400-97a9-8ae26913e540",
  "productndc": "37808-714",
  "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": "20181115",
  "active_numerator_strength": "125; 2"
}

Related drugs

Other records sharing ATC code P03AX.

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