🇺🇸
United States · US · US:0065-0395_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 · 1
- ndc1100650395151 BOTTLE, PLASTIC in 1 CARTON (0065-0395-15) / 15 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
736I6971TE
CYCLOPENTOLATE HYDROCHLORIDE
RxCUI 106029
Orange Book
A084109
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": "0065-0395_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1",
"productndc": "0065-0395",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "084109",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.5%",
"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": "ANDA084109",
"marketing_category": "ANDA",
"nonproprietary_name": "cyclopentolate hydrochloride",
"start_marketing_date": "19751015",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01FA54.
- 🇺🇸CyclogylAlcon Laboratories, Inc.
- 🇺🇸CyclogylAlcon Laboratories, Inc.
- 🇺🇸Cyclopentolate HydrochlorideBausch & Lomb Incorporated
- 🇺🇸Cyclopentolate HydrochlorideSandoz Inc.
- NOCyklopentolat-fenylefrin SASykehusapotekene HF
- GBMinims cyclopentolate hydrochloride 0.5% eye drops 0.5ml unit doseBausch & Lomb UK Ltd
- GBMinims cyclopentolate hydrochloride 1% eye drops 0.5ml unit doseBausch & Lomb UK Ltd
- GBMydrilate 0.5% solutionEsteve Pharmaceuticals Ltd
Access this data programmatically
Query Cyclogyl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.