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United States · US · US:71335-0425_8bde11c1-3380-437d-beda-1eb263058208

Dicyclomine Hydrochloride

Orange BookUNIISPLATC A03AA07

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA03AA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133504251
    30 TABLET in 1 BOTTLE (71335-0425-1)
  • ndc11
    7133504252
    40 TABLET in 1 BOTTLE (71335-0425-2)
  • ndc11
    7133504253
    60 TABLET in 1 BOTTLE (71335-0425-3)
  • ndc11
    7133504254
    90 TABLET in 1 BOTTLE (71335-0425-4)
  • ndc11
    7133504255
    20 TABLET in 1 BOTTLE (71335-0425-5)
  • ndc11
    7133504256
    21 TABLET in 1 BOTTLE (71335-0425-6)
  • ndc11
    7133504257
    120 TABLET in 1 BOTTLE (71335-0425-7)
  • ndc11
    7133504258
    100 TABLET in 1 BOTTLE (71335-0425-8)
  • ndc11
    7133504259
    28 TABLET in 1 BOTTLE (71335-0425-9)

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": "71335-0425_8bde11c1-3380-437d-beda-1eb263058208",
  "productndc": "71335-0425",
  "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

Other records sharing ATC code A03AA07.

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