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United States · US · US:71335-2341_8821239c-0d7f-4b89-90ba-554ca3e3d66a

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
    7133523411
    30 TABLET in 1 BOTTLE (71335-2341-1)
  • ndc11
    7133523412
    40 TABLET in 1 BOTTLE (71335-2341-2)
  • ndc11
    7133523413
    60 TABLET in 1 BOTTLE (71335-2341-3)
  • ndc11
    7133523414
    90 TABLET in 1 BOTTLE (71335-2341-4)
  • ndc11
    7133523415
    20 TABLET in 1 BOTTLE (71335-2341-5)
  • ndc11
    7133523416
    21 TABLET in 1 BOTTLE (71335-2341-6)
  • ndc11
    7133523417
    120 TABLET in 1 BOTTLE (71335-2341-7)
  • ndc11
    7133523418
    100 TABLET in 1 BOTTLE (71335-2341-8)
  • ndc11
    7133523419
    28 TABLET in 1 BOTTLE (71335-2341-9)

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A040317
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": "71335-2341_8821239c-0d7f-4b89-90ba-554ca3e3d66a",
  "productndc": "71335-2341",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040317",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Sep 7, 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": "ANDA040317",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine Hydrochloride",
  "start_marketing_date": "20230425",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A03AA07.

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