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United States · US · US:0904-6988_5d042b74-77b3-401e-b019-4807df743055

Dicyclomine Hydrochloride

Orange BookUNIISPLATC A03AA07

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeA03AA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0904698861
    100 BLISTER PACK in 1 CARTON (0904-6988-61) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A040230
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CQ903KQA31",
    "rxcui": "152021",
    "inchikey": "GUBNMFJOJGDCEL-UHFFFAOYSA-N",
    "display_name": "DICYCLOMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bb099db9-f635-4a64-8892-6236971dec45": {
      "match": "brand_token",
      "title": "DICYCLOMINE HYDROCHLORIDE SOLUTION [PAR HEALTH USA, LLC]",
      "spl_version": "8",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0904-6988_5d042b74-77b3-401e-b019-4807df743055",
  "productndc": "0904-6988",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040230",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Feb 26, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICYCLOMINE HYDROCHLORIDE",
  "proprietary_name": "Dicyclomine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040230",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine Hydrochloride",
  "start_marketing_date": "19990226",
  "active_numerator_strength": "20"
}

Related drugs

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