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United States · US · US:0409-0830_8664bd65-dcd7-420f-a8e3-01eaf3e02b36

Aztreonam

Orange BookUNIISPLATC J01DF01

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeJ01DF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409083001
    10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0830-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0830-11)

Annotations

UNII (FDA Substance ID)
G2B4VE5GH8
AZTREONAM
RxCUI 1272
Orange Book
A206517
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": "0409-0830_8664bd65-dcd7-420f-a8e3-01eaf3e02b36",
  "productndc": "0409-0830",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "206517",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/VIAL",
        "product_no": "001",
        "approval_date": "Nov 8, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/VIAL",
        "product_no": "002",
        "approval_date": "Nov 8, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZTREONAM",
  "proprietary_name": "Aztreonam",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA206517",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Aztreonam",
  "start_marketing_date": "20220124",
  "active_numerator_strength": "2"
}

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