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United States · US · US:70842-140_4c7649f3-4d38-47e2-aa0d-2ed606bb930a

Orbactiv

Orange BookUNIISPLATC J01XA05

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

Identification

ManufacturerMelinta Therapeutics, LLC
CountryUS (United States)
ATC codeJ01XA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7084214003
    3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)

Annotations

UNII (FDA Substance ID)
PUG62FRZ2E
ORITAVANCIN
RxCUI 1547611
Orange Book
N206334
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "PUG62FRZ2E",
    "rxcui": "1547611",
    "inchikey": "VHFGEBVPHAGQPI-LXKZPTCJSA-N",
    "display_name": "ORITAVANCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ff09a726-9f9b-4e30-b509-396781293220": {
      "match": "brand_token",
      "title": "ORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
      "spl_version": "12",
      "published_date": "2025-07-23"
    }
  },
  "productid": "70842-140_4c7649f3-4d38-47e2-aa0d-2ed606bb930a",
  "productndc": "70842-140",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "206334",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 400MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 6, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ORITAVANCIN",
  "proprietary_name": "Orbactiv",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA206334",
  "marketing_category": "NDA",
  "nonproprietary_name": "oritavancin",
  "start_marketing_date": "20140901",
  "active_numerator_strength": "400"
}

Related drugs

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