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United States · US · US:0480-3325_7fddacee-2401-4514-acf0-3847da11c6e5

Dalbavancin

Orange BookUNIISPLATC J01XA04

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

Identification

ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01XA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0480332501
    1 VIAL in 1 CARTON (0480-3325-01) / 25 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
33WDQ7T81E
DALBAVANCIN HYDROCHLORIDE
RxCUI 1541465
Orange Book
A219465
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "33WDQ7T81E",
    "rxcui": "1541465",
    "inchikey": null,
    "display_name": "DALBAVANCIN HYDROCHLORIDE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "2c2ec45e-48a2-4887-8ab0-9244eb39a394": {
      "match": "brand_token",
      "title": "DALBAVANCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "2",
      "published_date": "2026-04-16"
    }
  },
  "productid": "0480-3325_7fddacee-2401-4514-acf0-3847da11c6e5",
  "productndc": "0480-3325",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "219465",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 23, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DALBAVANCIN HYDROCHLORIDE",
  "proprietary_name": "Dalbavancin",
  "active_ingred_unit": "mg/25mL",
  "application_number": "ANDA219465",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dalbavancin",
  "start_marketing_date": "20251029",
  "active_numerator_strength": "500"
}

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