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United States · US · US:71715-001_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 · 1
- ndc11717150010210 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01)
Annotations
UNII (FDA Substance ID)
090IP5RV8F
OMADACYCLINE
RxCUI 2059269
Orange Book
N209817
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": "INTRAVENOUS",
"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": "71715-001_52cb2b5d-4a13-8b4a-e063-6294a90ad5b1",
"productndc": "71715-001",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "209817",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE/VIAL",
"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/5mL",
"application_number": "NDA209817",
"marketing_category": "NDA",
"nonproprietary_name": "omadacycline",
"start_marketing_date": "20190201",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J01AA15.
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