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United States · US · US:71335-2226_f2ba56dd-bb4e-4d75-ba92-2e3899a313b1

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
    7133522260
    10 TABLET in 1 BOTTLE (71335-2226-0)
  • ndc11
    7133522261
    30 TABLET in 1 BOTTLE (71335-2226-1)
  • ndc11
    7133522262
    40 TABLET in 1 BOTTLE (71335-2226-2)
  • ndc11
    7133522263
    60 TABLET in 1 BOTTLE (71335-2226-3)
  • ndc11
    7133522264
    90 TABLET in 1 BOTTLE (71335-2226-4)
  • ndc11
    7133522265
    20 TABLET in 1 BOTTLE (71335-2226-5)
  • ndc11
    7133522266
    21 TABLET in 1 BOTTLE (71335-2226-6)
  • ndc11
    7133522267
    120 TABLET in 1 BOTTLE (71335-2226-7)
  • ndc11
    7133522268
    100 TABLET in 1 BOTTLE (71335-2226-8)
  • ndc11
    7133522269
    28 TABLET in 1 BOTTLE (71335-2226-9)

Annotations

UNII (FDA Substance ID)
CQ903KQA31
DICYCLOMINE HYDROCHLORIDE
RxCUI 152021
Orange Book
A216736
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": "71335-2226_f2ba56dd-bb4e-4d75-ba92-2e3899a313b1",
  "productndc": "71335-2226",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216736",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 14, 2022"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Mar 25, 2025"
      }
    ],
    "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": "ANDA216736",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dicyclomine hydrochloride",
  "start_marketing_date": "20221214",
  "active_numerator_strength": "20"
}

Related drugs

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