🇺🇸
United States · US · US:70069-597_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0
Tetracaine Hydrochloride
Orange BookUNIISPLATC C05AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeC05AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170069597011 BOTTLE in 1 CARTON (70069-597-01) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5NF5D4OPCI
TETRACAINE HYDROCHLORIDE
RxCUI 91189
Orange Book
A217227
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5NF5D4OPCI",
"rxcui": "91189",
"inchikey": "PPWHTZKZQNXVAE-UHFFFAOYSA-N",
"display_name": "TETRACAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"f12d5944-0d6c-43ff-89fd-e0b5669e9b4a": {
"match": "brand_token",
"title": "TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.]",
"spl_version": "4",
"published_date": "2026-02-09"
}
},
"productid": "70069-597_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0",
"productndc": "70069-597",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "217227",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Dec 20, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TETRACAINE HYDROCHLORIDE",
"proprietary_name": "Tetracaine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217227",
"marketing_category": "ANDA",
"nonproprietary_name": "Tetracaine Hydrochloride",
"start_marketing_date": "20241223",
"active_numerator_strength": "5"
}Related drugs
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