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United States · US · US:82584-002_3891d7f3-d858-9f71-e063-6394a90af95b
BETIMOL
Orange BookUNIISPLATC C07AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerThea Pharma Inc.
CountryUS (United States)
ATC codeC07AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182584002051 BOTTLE, DROPPER in 1 CARTON (82584-002-05) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
817W3C6175
TIMOLOL
RxCUI 221172
Orange Book
N020439
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "817W3C6175",
"rxcui": "221172",
"inchikey": "TWBNMYSKRDRHAT-RCWTXCDDSA-N",
"display_name": "TIMOLOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"3ae775f4-340c-4bf4-aa49-8a31daba0f8b": {
"match": "brand_token",
"title": "BETIMOL (TIMOLOL) SOLUTION/ DROPS [THEA PHARMA INC.]",
"spl_version": "6",
"published_date": "2025-06-30"
}
},
"productid": "82584-002_3891d7f3-d858-9f71-e063-6394a90af95b",
"productndc": "82584-002",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "020439",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.25%",
"product_no": "001",
"approval_date": "Mar 31, 1995"
},
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "0.5%",
"product_no": "002",
"approval_date": "Mar 31, 1995"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIMOLOL",
"proprietary_name": "BETIMOL",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020439",
"marketing_category": "NDA",
"nonproprietary_name": "timolol",
"start_marketing_date": "20221115",
"active_numerator_strength": "5.12"
}Related drugs
Other records sharing ATC code C07AA06.
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