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United States · US · US:70842-120_163f9a07-823d-4c53-9136-8783e95f9cdc

VABOMERE

Orange BookUNIISPLATC J01DH

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

Identification

ManufacturerMelinta Therapeutics, LLC
CountryUS (United States)
ATC codeJ01DH
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7084212006
    6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01)

Annotations

UNII (FDA Substance ID)
FV9J3JU8B1
MEROPENEM
RxCUI 29561
Orange Book
N209776
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FV9J3JU8B1",
    "rxcui": "29561",
    "inchikey": "CTUAQTBUVLKNDJ-OBZXMJSBSA-N",
    "display_name": "MEROPENEM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e237fd0f-3050-42a3-b43e-b6fb4824e93d": {
      "match": "brand_token",
      "title": "VABOMERE (MEROPENEM-VABORBACTAM) INJECTION, POWDER, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
      "spl_version": "14",
      "published_date": "2026-03-09"
    }
  },
  "productid": "70842-120_163f9a07-823d-4c53-9136-8783e95f9cdc",
  "productndc": "70842-120",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "209776",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM/VIAL;1GM/VIAL",
        "product_no": "001",
        "approval_date": "Aug 29, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEROPENEM; VABORBACTAM",
  "proprietary_name": "VABOMERE",
  "active_ingred_unit": "g/2g; g/2g",
  "application_number": "NDA209776",
  "marketing_category": "NDA",
  "nonproprietary_name": "Meropenem-Vaborbactam",
  "start_marketing_date": "20171002",
  "active_numerator_strength": "1; 1"
}

Related drugs

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