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United States · US · US:71773-050_77aceb1e-e4ae-4416-8f32-7ebe72348488

Xerava

Orange BookUNIISPLATC J01AA13

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

Identification

ManufacturerTetraphase Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01AA13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7177305005
    1 VIAL, GLASS in 1 CARTON (71773-050-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
  • ndc11
    7177305012
    12 VIAL, GLASS in 1 CARTON (71773-050-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
WK1NMH89VJ
ERAVACYCLINE DIHYDROCHLORIDE
RxCUI 2055907
Orange Book
N211109
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK1NMH89VJ",
    "rxcui": "2055907",
    "inchikey": "JYCNMRVZELJVAW-RZVFYPHASA-N",
    "display_name": "ERAVACYCLINE DIHYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a4b188d4-f467-470c-ad7b-25ffbdd8862a": {
      "match": "brand_token",
      "title": "XERAVA (ERAVACYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TETRAPHASE PHARMACEUTICALS, INC.]",
      "spl_version": "11",
      "published_date": "2025-09-29"
    }
  },
  "productid": "71773-050_77aceb1e-e4ae-4416-8f32-7ebe72348488",
  "productndc": "71773-050",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "211109",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 27, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jun 3, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERAVACYCLINE DIHYDROCHLORIDE",
  "proprietary_name": "Xerava",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211109",
  "marketing_category": "NDA",
  "nonproprietary_name": "eravacycline",
  "start_marketing_date": "20180910",
  "active_numerator_strength": "50"
}

Related drugs

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