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United States · US · US:0998-0016_5468200d-d85e-4e90-928b-84a91e05185b
Alcaine
Orange BookUNIISPLATC S01HA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeS01HA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1109980016151 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
U96OL57GOY
PROPARACAINE HYDROCHLORIDE
RxCUI 227778
Orange Book
A080027
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U96OL57GOY",
"rxcui": "227778",
"inchikey": "BFUUJUGQJUTPAF-UHFFFAOYSA-N",
"display_name": "PROPARACAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"0c0fa0bf-977d-4539-b8dc-54c187c5b094": {
"match": "brand_token",
"title": "ALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]",
"spl_version": "11",
"published_date": "2024-07-22"
}
},
"productid": "0998-0016_5468200d-d85e-4e90-928b-84a91e05185b",
"productndc": "0998-0016",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "080027",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"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": "PROPARACAINE HYDROCHLORIDE",
"proprietary_name": "Alcaine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA080027",
"marketing_category": "ANDA",
"nonproprietary_name": "proparacaine hydrochloride",
"start_marketing_date": "19731019",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01HA04.
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