NDC 69097-820-37 - 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
- 69097-820
- Requested NDC
- 69097-820-37
- Package NDCs from labels
- 69097-820-37, 69097-820-96
- Manufacturer
- Cipla USA Inc. | Hovione FarmaCiencia SA (Hovione Portugal) | Solvias AG | Hospira, Inc. | AndersonBrecon (dba Packaging Coordinators Inc.) | North American Science Associates, Inc. (NAMSA) | Eurofins Lancaster Laboratories, Inc
- Effective date
- 2024-12-20
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Zemdri (plazomicin) | Cipla USA Inc. | Hovione FarmaCiencia SA (Hovione Portugal) | Solvias AG | Hospira, Inc. | AndersonBrecon (dba Packaging Coordinators Inc.) | North American Science Associates, Inc. (NAMSA) | Eurofins Lancaster Laboratories, Inc | 2024-12-20 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69097-820-37 | Zemdri (plazomicin) | 10 mL in 1 VIAL | INJECTION | 10 | 4 | |
| 69097-820-96 | Zemdri (plazomicin) | 10 in 1 CARTON | INJECTION | 10 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69097-820-37 | ML - Milliliter | 69097-820 | 802e0449-ef6c-41e6-b54e-f6bcd14631ee | 1 | 2020-05-08 |
| 69097-820-96 | ML - Milliliter | 69097-820 | d86dbe3d-6673-4e4d-b395-b9fc02ca0f96 | 1 | 2020-05-08 |
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.
| 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 | NDA210303 2049558 2049553 LYO9XZ250J |
| Sterile Water | WATER | Baxter Healthcare Corporation | ef3e79c5-3f58-4b36-a296-64b7d9a651c1 | 2017-10-17 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye Wash | WATER | CVS Pharmacy | 049cee29-7ec2-4d5b-8308-f522acde43a7 | 2017-03-29 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.