🇺🇸
United States · US · US:0065-0397_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1
Cyclogyl
Orange BookUNIISPLATC S01FA54
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeS01FA54
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1100650397021 BOTTLE, PLASTIC in 1 CARTON (0065-0397-02) / 2 mL in 1 BOTTLE, PLASTIC
- ndc1100650397051 BOTTLE, PLASTIC in 1 CARTON (0065-0397-05) / 5 mL in 1 BOTTLE, PLASTIC
- ndc1100650397151 BOTTLE, PLASTIC in 1 CARTON (0065-0397-15) / 15 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
736I6971TE
CYCLOPENTOLATE HYDROCHLORIDE
RxCUI 106029
Orange Book
A084108
AT
DailyMed SPL labels
1 version tracked
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",
"spl_meta": {
"1d008c76-7210-4ace-90fa-7cd22762e12e": {
"match": "brand_token",
"title": "CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]",
"spl_version": "15",
"published_date": "2024-06-27"
}
},
"productid": "0065-0397_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1",
"productndc": "0065-0397",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "084108",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "2%",
"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": "Cyclogyl",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA084108",
"marketing_category": "ANDA",
"nonproprietary_name": "cyclopentolate hydrochloride",
"start_marketing_date": "19751015",
"active_numerator_strength": "20"
}Related drugs
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- GBMinims cyclopentolate hydrochloride 1% eye drops 0.5ml unit doseBausch & Lomb UK Ltd
- GBMydrilate 0.5% solutionEsteve Pharmaceuticals Ltd
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