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United States · US · US:61314-396_6b554ca9-699a-4d71-8e46-0130c675ca3c

Cyclopentolate Hydrochloride

Orange BookUNIIATC S01FA54

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

Identification

ManufacturerSandoz Inc.
CountryUS (United States)
ATC codeS01FA54
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6131439601
    2 mL in 1 BOTTLE (61314-396-01)
  • ndc11
    6131439602
    5 mL in 1 BOTTLE (61314-396-02)
  • ndc11
    6131439603
    15 mL in 1 BOTTLE (61314-396-03)

Annotations

UNII (FDA Substance ID)
736I6971TE
CYCLOPENTOLATE HYDROCHLORIDE
RxCUI 106029
Orange Book
A084110
AT
Raw payload (JSON)
{
  "unii": {
    "unii": "736I6971TE",
    "rxcui": "106029",
    "inchikey": "RHKZVMUBMXGOLL-UHFFFAOYSA-N",
    "display_name": "CYCLOPENTOLATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "productid": "61314-396_6b554ca9-699a-4d71-8e46-0130c675ca3c",
  "productndc": "61314-396",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "084110",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOPENTOLATE HYDROCHLORIDE",
  "proprietary_name": "Cyclopentolate Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA084110",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclopentolate Hydrochloride",
  "start_marketing_date": "20020822",
  "active_numerator_strength": "10"
}

Related drugs

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