zemdri (plazomicin)

Generic: plazomicin

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zemdri (plazomicin)
Generic Name plazomicin
Labeler cipla usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

plazomicin 500 mg/10mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-820
Product ID 69097-820_b2d9319a-6c34-4851-8486-3d956e916f53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210303
Listing Expiration 2026-12-31
Marketing Start 2018-07-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097820
Hyphenated Format 69097-820

Supplemental Identifiers

RxCUI
2049553 2049558
UNII
LYO9XZ250J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zemdri (plazomicin) (source: ndc)
Generic Name plazomicin (source: ndc)
Application Number NDA210303 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37)
source: ndc

Packages (1)

69097-820-96 10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37)

Ingredients (1)

plazomicin (500 mg/10mL)

Linked Drug Pages (1)

Zemdri (plazomicin) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b2d9319a-6c34-4851-8486-3d956e916f53", "openfda": {"unii": ["LYO9XZ250J"], "rxcui": ["2049553", "2049558"], "spl_set_id": ["eccf9fd9-53ac-4252-a106-5567b3a82a70"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (69097-820-96)  / 10 mL in 1 VIAL (69097-820-37)", "package_ndc": "69097-820-96", "marketing_start_date": "20180716"}], "brand_name": "Zemdri (plazomicin)", "product_id": "69097-820_b2d9319a-6c34-4851-8486-3d956e916f53", "dosage_form": "INJECTION", "product_ndc": "69097-820", "generic_name": "Plazomicin", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zemdri (plazomicin)", "active_ingredients": [{"name": "PLAZOMICIN", "strength": "500 mg/10mL"}], "application_number": "NDA210303", "marketing_category": "NDA", "marketing_start_date": "20180716", "listing_expiration_date": "20261231"}