🇺🇸
United States · US · US:68682-920_48ec9821-6f9b-2a1b-e063-6394a90a1d98
Tetracaine Hydrochloride
Orange BookUNIISPLATC C05AD02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeC05AD02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168682920051 BOTTLE in 1 CARTON (68682-920-05) / 5 mL in 1 BOTTLE
- ndc1168682920641 BOTTLE in 1 CARTON (68682-920-64) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5NF5D4OPCI
TETRACAINE HYDROCHLORIDE
RxCUI 91189
Orange Book
N210821
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": "68682-920_48ec9821-6f9b-2a1b-e063-6394a90a1d98",
"productndc": "68682-920",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "210821",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB1",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Mar 12, 2019"
}
],
"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": "NDA210821",
"marketing_category": "NDA",
"nonproprietary_name": "Tetracaine Hydrochloride",
"start_marketing_date": "20190627",
"active_numerator_strength": "5"
}Related drugs
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