NDC 71045-010-01 - Zemdri (plazomicin)

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 71045-010
Requested NDC: 71045-010-01
Package NDCs from labels: 71045-010-01, 71045-010-02
Manufacturer: Achaogen, Inc. | Hovione FarmaCiencia SA (Hovione Portugal) | Solvias AG | Hospira, Inc. | AndersonBrecon (dba Packaging Coordinators Inc.) | North American Science Associates, Inc. (NAMSA)
Effective date: 2018-06-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Zemdri (plazomicin)	Achaogen, Inc. \| Hovione FarmaCiencia SA (Hovione Portugal) \| Solvias AG \| Hospira, Inc. \| AndersonBrecon (dba Packaging Coordinators Inc.) \| North American Science Associates, Inc. (NAMSA)	2018-06-29	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71045-010-01	Zemdri (plazomicin)	10 mL in 1 VIAL	INJECTION	10		1
71045-010-02	Zemdri (plazomicin)	10 in 1 CARTON	INJECTION	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71045-010	ZEMDRI (PLAZOMICIN) (PLAZOMICIN) INJECTION [ACHAOGEN, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20180716_0b82ffed-27f4-4f5c-8135-670c148f0e12.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71045-010-01	ML - Milliliter	71045-010	3bed25b0-d9c1-4c7d-8c78-86dc61c25ac2	1	2018-08-13
71045-010-02	ML - Milliliter	71045-010	c809c83d-dd05-47cb-aea5-c331615771a1	1	2018-08-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 9 of 9 · 164 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zemdri (plazomicin)	PLAZOMICIN	Achaogen, Inc.	0b82ffed-27f4-4f5c-8135-670c148f0e12	2018-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA210303 ndc (package): 71045-010-02 ndc (package): 71045-010-01 ndc (product): 71045-010 ndc11 (package): 71045001001 rxcui: 2049558 rxcui: 2049553 spl id: 7803b863-697d-4d96-911f-5a229bbd8272 spl set id: 0b82ffed-27f4-4f5c-8135-670c148f0e12 unii: LYO9XZ250J
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.