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United States · US · US:24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4
Istalol
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1124208004011 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1124208004021 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1124208004031 BOTTLE, DROPPER in 1 CARTON (24208-004-03) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
P8Y54F701R
TIMOLOL MALEATE
RxCUI 42933
Orange Book
N021516
AT2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P8Y54F701R",
"rxcui": "42933",
"inchikey": "WLRMANUAADYWEA-NWASOUNVSA-N",
"display_name": "TIMOLOL MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"258bbc8d-00ee-45b0-ac35-6f16c4e8d45f": {
"match": "brand_token",
"title": "ISTALOL (TIMOLOL MALEATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]",
"spl_version": "22",
"published_date": "2024-11-01"
}
},
"productid": "24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4",
"productndc": "24208-004",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "021516",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT2",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Jun 4, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL MALEATE",
"proprietary_name": "Istalol",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021516",
"marketing_category": "NDA",
"nonproprietary_name": "Timolol Maleate",
"start_marketing_date": "20040802",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA06.
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