Back to search
🇺🇸

United States · US · US:0003-2570_1308cf65-8900-4fc3-8a41-47b766adbd3a

AZACTAM

Orange BookUNIISPLATC J01DF01

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

Identification

ManufacturerE.R. Squibb & Sons, L.L.C.
CountryUS (United States)
ATC codeJ01DF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0003257016
    10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2570-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
G2B4VE5GH8
AZTREONAM
RxCUI 1272
Orange Book
N050580
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": {
    "9a105eaf-ee77-4016-beeb-d425a5565db2": {
      "match": "brand_token",
      "title": "AZACTAM (AZTREONAM) INJECTION, POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.]",
      "spl_version": "15",
      "published_date": "2025-12-23"
    }
  },
  "productid": "0003-2570_1308cf65-8900-4fc3-8a41-47b766adbd3a",
  "productndc": "0003-2570",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "050580",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 31, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1GM/VIAL",
        "product_no": "002",
        "approval_date": "Dec 31, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2GM/VIAL",
        "product_no": "003",
        "approval_date": "Dec 31, 1986"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZTREONAM",
  "proprietary_name": "AZACTAM",
  "active_ingred_unit": "g/1",
  "application_number": "NDA050580",
  "marketing_category": "NDA",
  "nonproprietary_name": "AZTREONAM",
  "start_marketing_date": "20100401",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code J01DF01.

Access this data programmatically

Query AZACTAM and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.