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United States · US · US:71335-0471_2d59c9b7-f4c2-4976-9681-a7fcec24498b

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
    7133504711
    30 CAPSULE in 1 BOTTLE (71335-0471-1)
  • ndc11
    7133504712
    90 CAPSULE in 1 BOTTLE (71335-0471-2)
  • ndc11
    7133504713
    40 CAPSULE in 1 BOTTLE (71335-0471-3)
  • ndc11
    7133504714
    60 CAPSULE in 1 BOTTLE (71335-0471-4)
  • ndc11
    7133504715
    20 CAPSULE in 1 BOTTLE (71335-0471-5)
  • ndc11
    7133504716
    100 CAPSULE in 1 BOTTLE (71335-0471-6)
  • ndc11
    7133504717
    180 CAPSULE in 1 BOTTLE (71335-0471-7)
  • ndc11
    7133504718
    120 CAPSULE in 1 BOTTLE (71335-0471-8)
  • ndc11
    7133504719
    10 CAPSULE in 1 BOTTLE (71335-0471-9)

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A084285
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": "71335-0471_2d59c9b7-f4c2-4976-9681-a7fcec24498b",
  "productndc": "71335-0471",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "084285",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "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": "ANDA084285",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine Hydrochloride",
  "start_marketing_date": "19740930",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A03AA07.

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