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United States · US · US:71045-010_7803b863-697d-4d96-911f-5a229bbd8272
Zemdri (plazomicin)
Orange BookUNIISPLATC J01GB14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAchaogen, Inc.
CountryUS (United States)
ATC codeJ01GB14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11710450100210 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01)
Annotations
UNII (FDA Substance ID)
LYO9XZ250J
PLAZOMICIN
RxCUI 2049549
Orange Book
N210303
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "LYO9XZ250J",
"rxcui": "2049549",
"inchikey": "IYDYFVUFSPQPPV-PEXOCOHZSA-N",
"display_name": "PLAZOMICIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"eccf9fd9-53ac-4252-a106-5567b3a82a70": {
"match": "brand_token",
"title": "ZEMDRI (PLAZOMICIN) (PLAZOMICIN) INJECTION [CIPLA USA INC.]",
"spl_version": "4",
"published_date": "2024-12-23"
}
},
"productid": "71045-010_7803b863-697d-4d96-911f-5a229bbd8272",
"productndc": "71045-010",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210303",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 500MG BASE/10ML (EQ 50MG BASE/ML)",
"product_no": "001",
"approval_date": "Jun 25, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PLAZOMICIN",
"proprietary_name": "Zemdri (plazomicin)",
"active_ingred_unit": "mg/10mL",
"application_number": "NDA210303",
"marketing_category": "NDA",
"nonproprietary_name": "Plazomicin",
"start_marketing_date": "20180716",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01GB14.
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