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United States · US · US:0074-3878_c35160ee-d73c-4288-8172-d69d75d52b1d

EMBLAVEO

Orange BookUNIISPLATC J01DF

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

Identification

ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeJ01DF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0074387810
    10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)

Annotations

UNII (FDA Substance ID)
7352665165
AVIBACTAM
RxCUI 1603834
Orange Book
N217906
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7352665165",
    "rxcui": "1603834",
    "inchikey": "NDCUAPJVLWFHHB-UHNVWZDZSA-N",
    "display_name": "AVIBACTAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "be1a6c99-d4b3-46d7-9e99-6e5f9fab556a": {
      "match": "brand_token",
      "title": "EMBLAVEO (AZTREONAM AND AVIBACTAM) POWDER, FOR SOLUTION [ABBVIE INC.]",
      "spl_version": "5",
      "published_date": "2026-04-17"
    }
  },
  "productid": "0074-3878_c35160ee-d73c-4288-8172-d69d75d52b1d",
  "productndc": "0074-3878",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "217906",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5GM BASE/VIAL;1.5GM/VIAL",
        "product_no": "001",
        "approval_date": "Feb 7, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AVIBACTAM; AZTREONAM",
  "proprietary_name": "EMBLAVEO",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA217906",
  "marketing_category": "NDA",
  "nonproprietary_name": "aztreonam and avibactam",
  "start_marketing_date": "20250207",
  "active_numerator_strength": "42.3; 127"
}

Related drugs

Other records sharing ATC code J01DF.

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