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United States · US · US:71205-428_254cd89b-86ad-4846-a5d3-5fe66e0d1e81

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
    7120542815
    15 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-15)
  • ndc11
    7120542820
    20 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-20)
  • ndc11
    7120542830
    30 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-30)
  • ndc11
    7120542860
    60 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-60)
  • ndc11
    7120542890
    90 CAPSULE in 1 BOTTLE, PLASTIC (71205-428-90)

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A085082
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": "71205-428_254cd89b-86ad-4846-a5d3-5fe66e0d1e81",
  "productndc": "71205-428",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "085082",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 19, 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": "ANDA085082",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine Hydrochloride",
  "start_marketing_date": "19860619",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A03AA07.

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