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United States · US · US:68788-4090_82111bef-460f-4948-a19c-1d2063427ee4

LIDOCAINE AND PRILOCAINE

Orange BookUNIISPLATC C01BB

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC01BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6878840903
    1 TUBE in 1 CARTON (68788-4090-3) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
98PI200987
LIDOCAINE
RxCUI 6387
Orange Book
A212482
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": "68788-4090_82111bef-460f-4948-a19c-1d2063427ee4",
  "productndc": "68788-4090",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "212482",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5%;2.5%",
        "product_no": "001",
        "approval_date": "Jul 27, 2021"
      }
    ],
    "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": "ANDA212482",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lidocaine and Prilocaine",
  "start_marketing_date": "20260317",
  "active_numerator_strength": "25; 25"
}

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