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United States · US · US:63187-784_2bab7712-de3d-45a1-a21c-b6273721bb28

Dicyclomine Hydrochloride

Orange BookUNIISPLATC A03AA07

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA03AA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6318778415
    15 TABLET in 1 BOTTLE, PLASTIC (63187-784-15)
  • ndc11
    6318778420
    20 TABLET in 1 BOTTLE, PLASTIC (63187-784-20)
  • ndc11
    6318778430
    30 TABLET in 1 BOTTLE, PLASTIC (63187-784-30)
  • ndc11
    6318778460
    60 TABLET in 1 BOTTLE, PLASTIC (63187-784-60)
  • ndc11
    6318778490
    90 TABLET in 1 BOTTLE, PLASTIC (63187-784-90)

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A085223
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": "63187-784_2bab7712-de3d-45a1-a21c-b6273721bb28",
  "productndc": "63187-784",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "085223",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jul 30, 1986"
      }
    ],
    "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": "ANDA085223",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine Hydrochloride",
  "start_marketing_date": "19860730",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A03AA07.

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