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United States · US · US:71085-100_4c97e0ed-1d3a-44af-e063-6294a90ae75f

PLIAGLIS

Orange BookUNIISPLATC C01BB

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

Identification

ManufacturerIPG PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeC01BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7108510030
    1 TUBE in 1 CARTON (71085-100-30) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
98PI200987
LIDOCAINE
RxCUI 6387
Orange Book
N021717
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": {
    "d854faa5-0af8-4684-b5cd-a0b8a91fb7cd": {
      "match": "brand_token",
      "title": "PLIAGLIS (LIDOCAINE AND TETRACAINE) CREAM [IPG PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-03-10"
    }
  },
  "productid": "71085-100_4c97e0ed-1d3a-44af-e063-6294a90ae75f",
  "productndc": "71085-100",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "021717",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7%;7%",
        "product_no": "001",
        "approval_date": "Jun 29, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LIDOCAINE; TETRACAINE",
  "proprietary_name": "PLIAGLIS",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "NDA021717",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lidocaine and Tetracaine",
  "start_marketing_date": "20260306",
  "active_numerator_strength": "70; 70"
}

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