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United States · US · US:71715-002_52cb2b5d-4a13-8b4a-e063-6294a90ad5b1

NUZYRA

Orange BookUNIISPLATC J01AA15

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

Identification

ManufacturerParatek Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01AA15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7171500221
    1 BLISTER PACK in 1 CARTON (71715-002-21) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)
  • ndc11
    7171500227
    5 BLISTER PACK in 1 CARTON (71715-002-27) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)

Annotations

UNII (FDA Substance ID)
090IP5RV8F
OMADACYCLINE
RxCUI 2059269
Orange Book
N209816
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "090IP5RV8F",
    "rxcui": "2059269",
    "inchikey": "JEECQCWWSTZDCK-IQZGDKDPSA-N",
    "display_name": "OMADACYCLINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "51591524-4703-44c6-8bde-dce3e6a463d1": {
      "match": "brand_token",
      "title": "NUZYRA (OMADACYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION NUZYRA (OMADACYCLINE) TABLET, FILM COATED [PARATEK PHARMACEUTICALS, INC.]",
      "spl_version": "12",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71715-002_52cb2b5d-4a13-8b4a-e063-6294a90ad5b1",
  "productndc": "71715-002",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209816",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Oct 2, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMADACYCLINE",
  "proprietary_name": "NUZYRA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209816",
  "marketing_category": "NDA",
  "nonproprietary_name": "omadacycline",
  "start_marketing_date": "20190201",
  "active_numerator_strength": "150"
}

Related drugs

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