Back to search
🇺🇸

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

  • ndc11
    7104501002
    10 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.

Access this data programmatically

Query Zemdri (plazomicin) and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.