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United States · US · US:0121-1002_1beba651-25b0-4be2-88b2-c85b655ee5c3

Lidocaine and Prilocaine

Orange BookUNIISPLATC C01BB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeC01BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0121100230
    1 TUBE in 1 CARTON (0121-1002-30) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
98PI200987
LIDOCAINE
RxCUI 6387
Orange Book
A205887
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": "0121-1002_1beba651-25b0-4be2-88b2-c85b655ee5c3",
  "productndc": "0121-1002",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "205887",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5%;2.5%",
        "product_no": "001",
        "approval_date": "Jun 29, 2018"
      }
    ],
    "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": "ANDA205887",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lidocaine and Prilocaine",
  "start_marketing_date": "20250206",
  "active_numerator_strength": "25; 25"
}

Related drugs

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