🇺🇸
United States · US · US:0168-0357_73a2a608-dd5c-4357-85f3-00358b9c6ccc
Lidocaine and Prilocaine
Orange BookUNIISPLATC C01BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC01BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1101680357301 TUBE in 1 CARTON (0168-0357-30) / 30 g in 1 TUBE
- ndc1101680357551 TUBE in 1 CARTON (0168-0357-55) / 5 g in 1 TUBE (0168-0357-05)
- ndc1101680357561 TUBE in 1 CARTON (0168-0357-56) / 5 g in 1 TUBE (0168-0357-05)
Annotations
UNII (FDA Substance ID)
98PI200987
LIDOCAINE
RxCUI 6387
Orange Book
A076453
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "98PI200987",
"rxcui": "6387",
"inchikey": "NNJVILVZKWQKPM-UHFFFAOYSA-N",
"display_name": "LIDOCAINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"4db609cc-f329-62a4-e063-6394a90aefc1": {
"match": "brand_token",
"title": "LIDOCAINE GEL [YYBA CORP]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "0168-0357_73a2a608-dd5c-4357-85f3-00358b9c6ccc",
"productndc": "0168-0357",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "076453",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "2.5%;2.5%",
"product_no": "001",
"approval_date": "Aug 18, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LIDOCAINE; PRILOCAINE",
"proprietary_name": "Lidocaine and Prilocaine",
"active_ingred_unit": "mg/g; mg/g",
"application_number": "ANDA076453",
"marketing_category": "ANDA",
"nonproprietary_name": "lidocaine and prilocaine",
"start_marketing_date": "20030818",
"active_numerator_strength": "25; 25"
}Related drugs
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