Steritalc

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovatech SA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6232744444
4 VIAL, GLASS in 1 BOX (62327-444-44) / 50 mL in 1 VIAL, GLASS (62327-444-04)

Annotations

UNII (FDA Substance ID)

7SEV7J4R1U

TALC

RxCUI 10323

Orange Book

N205555

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "7SEV7J4R1U",
    "rxcui": "10323",
    "inchikey": "QLQXSZZVUVMFHZ-UHFFFAOYSA-L",
    "display_name": "TALC",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAPLEURAL",
  "spl_meta": {
    "c94e51d9-beef-4b06-e053-2a95a90a754a": {
      "match": "brand_token",
      "title": "STERITALC 4G (TALC) POWDER STERITALC 2G (TALC) POWDER STERITALC 3G (TALC) POWDER [NOVATECH SA]",
      "spl_version": "7",
      "published_date": "2025-06-27"
    }
  },
  "productid": "62327-444_386130d4-1b0d-5e87-e063-6394a90aefa7",
  "productndc": "62327-444",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "205555",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2GM/VIAL",
        "product_no": "001",
        "approval_date": "May 1, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3GM/VIAL",
        "product_no": "002",
        "approval_date": "May 1, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4GM/VIAL",
        "product_no": "003",
        "approval_date": "May 1, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TALC",
  "proprietary_name": "Steritalc",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA205555",
  "marketing_category": "NDA",
  "nonproprietary_name": "Talc",
  "start_marketing_date": "20170801",
  "active_numerator_strength": "4"
}

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