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United States · US · US:0078-0729_c0cc485e-81d4-4204-a894-caa615bea90b
Betoptic S
Orange BookUNIISPLATC S01ED52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeS01ED52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100780729101 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE
- ndc1100780729151 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
6X97D2XT0O
BETAXOLOL HYDROCHLORIDE
RxCUI 142144
Orange Book
N019845
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6X97D2XT0O",
"rxcui": "142144",
"inchikey": "CHDPSNLJFOQTRK-UHFFFAOYSA-N",
"display_name": "BETAXOLOL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"905ba189-456c-4aa4-8231-39a971374ad8": {
"match": "brand_token",
"title": "BETOPTIC S (BETAXOLOL HYDROCHLORIDE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "4",
"published_date": "2025-01-23"
}
},
"productid": "0078-0729_c0cc485e-81d4-4204-a894-caa615bea90b",
"productndc": "0078-0729",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "019845",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.25% BASE",
"product_no": "001",
"approval_date": "Dec 29, 1989"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BETAXOLOL HYDROCHLORIDE",
"proprietary_name": "Betoptic S",
"active_ingred_unit": "mg/mL",
"application_number": "NDA019845",
"marketing_category": "NDA",
"nonproprietary_name": "betaxolol hydrochloride",
"start_marketing_date": "19960115",
"active_numerator_strength": "2.8"
}Related drugs
Other records sharing ATC code S01ED52.
- 🇺🇸BetaxololPuraCap Laboratories LLC
- 🇺🇸BetaxololPuraCap Laboratories LLC
- 🇺🇸BetaxololEpic Pharma LLC
- 🇺🇸BetaxololEpic Pharma LLC
- GBBetaxolol 0.25% eye dropsSigma Pharmaceuticals Plc
- GBBetaxolol 0.25% eye drops 0.25ml unit dose preservative freeColorama Pharmaceuticals Ltd
- GBBetaxolol 0.5% eye dropsWaymade Healthcare Plc
- GBBetaxolol 0.5% eye dropsAlliance Healthcare (Distribution) Ltd
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