🇺🇸
United States · US · US:70518-4183_35bf62a6-b5a0-9582-e063-6394a90a1b92
Tetracaine Hydrochloride
Orange BookUNIISPLATC C05AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC05AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705184183012 BOTTLE, DROPPER in 1 CARTON (70518-4183-0) / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1)
Annotations
UNII (FDA Substance ID)
5NF5D4OPCI
TETRACAINE HYDROCHLORIDE
RxCUI 91189
Orange Book
N208135
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": "70518-4183_35bf62a6-b5a0-9582-e063-6394a90a1b92",
"productndc": "70518-4183",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "208135",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.5%",
"product_no": "001",
"approval_date": "Feb 29, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TETRACAINE HYDROCHLORIDE",
"proprietary_name": "Tetracaine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208135",
"marketing_category": "NDA",
"nonproprietary_name": "tetracaine hydrochloride",
"start_marketing_date": "20240924",
"active_numerator_strength": "5"
}Related drugs
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