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United States · US · US:72888-119_4b7e07c5-f687-74a5-e063-6294a90aa7ef

Dicyclomine hydrochloride

Orange BookUNIISPLATC A03AA07

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

Identification

ManufacturerAdvagen Pharma Ltd.,
CountryUS (United States)
ATC codeA03AA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7288811900
    1000 TABLET in 1 BOTTLE (72888-119-00)
  • ndc11
    7288811901
    100 TABLET in 1 BOTTLE (72888-119-01)
  • ndc11
    7288811905
    500 TABLET in 1 BOTTLE (72888-119-05)
  • ndc11
    7288811930
    30 TABLET in 1 BOTTLE (72888-119-30)

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A216736
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": "72888-119_4b7e07c5-f687-74a5-e063-6294a90aa7ef",
  "productndc": "72888-119",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216736",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 14, 2022"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Mar 25, 2025"
      }
    ],
    "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": "ANDA216736",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine hydrochloride",
  "start_marketing_date": "20221214",
  "active_numerator_strength": "20"
}

Related drugs

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