Aztreonam

Orange BookUNIISPLATC J01DF01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeJ01DF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332340120
10 VIAL in 1 TRAY (63323-401-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-01)

Annotations

UNII (FDA Substance ID)

G2B4VE5GH8

AZTREONAM

RxCUI 1272

Orange Book

A065439

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "G2B4VE5GH8",
    "rxcui": "1272",
    "inchikey": "WZPBZJONDBGPKJ-VEHQQRBSSA-N",
    "display_name": "AZTREONAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "d4500795-3b07-4a7d-b432-73cafbb3dbc6": {
      "match": "brand_token",
      "title": "AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]",
      "spl_version": "3",
      "published_date": "2024-06-17"
    }
  },
  "productid": "63323-401_b6926b10-085f-4255-b4f1-24572a7ef57a",
  "productndc": "63323-401",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065439",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 18, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/VIAL",
        "product_no": "002",
        "approval_date": "Jun 18, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/VIAL",
        "product_no": "003",
        "approval_date": "Jun 18, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZTREONAM",
  "proprietary_name": "Aztreonam",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA065439",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AZTREONAM",
  "start_marketing_date": "20091105",
  "active_numerator_strength": "1"
}

Related drugs

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