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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

  • ndc11
    0168035730
    1 TUBE in 1 CARTON (0168-0357-30) / 30 g in 1 TUBE
  • ndc11
    0168035755
    1 TUBE in 1 CARTON (0168-0357-55) / 5 g in 1 TUBE (0168-0357-05)
  • ndc11
    0168035756
    1 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

Other records sharing ATC code C01BB.

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