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United States · US · US:71335-2506_2c521bdf-ff4d-47e3-8776-0ba6e5e6613b

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 · 10

  • ndc11
    7133525060
    10 TABLET in 1 BOTTLE (71335-2506-0)
  • ndc11
    7133525061
    30 TABLET in 1 BOTTLE (71335-2506-1)
  • ndc11
    7133525062
    40 TABLET in 1 BOTTLE (71335-2506-2)
  • ndc11
    7133525063
    60 TABLET in 1 BOTTLE (71335-2506-3)
  • ndc11
    7133525064
    90 TABLET in 1 BOTTLE (71335-2506-4)
  • ndc11
    7133525065
    20 TABLET in 1 BOTTLE (71335-2506-5)
  • ndc11
    7133525066
    21 TABLET in 1 BOTTLE (71335-2506-6)
  • ndc11
    7133525067
    120 TABLET in 1 BOTTLE (71335-2506-7)
  • ndc11
    7133525068
    100 TABLET in 1 BOTTLE (71335-2506-8)
  • ndc11
    7133525069
    28 TABLET in 1 BOTTLE (71335-2506-9)

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A217916
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": "71335-2506_2c521bdf-ff4d-47e3-8776-0ba6e5e6613b",
  "productndc": "71335-2506",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217916",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 4, 2023"
      }
    ],
    "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": "ANDA217916",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine Hydrochloride",
  "start_marketing_date": "20230913",
  "active_numerator_strength": "20"
}

Related drugs

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