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 | 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 | 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#
DailyMed Billing Units#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b83 | 2025-01-09 | Warnings, Adverse reactions | 059QF0KO0R |
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 7610bf80-61b7-982f-e053-2a91aa0ac1bb | 2025-01-09 | Warnings, Adverse reactions | 059QF0KO0R |
| T-27 | WATER | DNA Labs, Inc. | f0e9afd7-64a4-4b85-9c5f-4bf07ba4b481 | 2025-01-09 | Warnings | 059QF0KO0R |
| Sterile Water | STERILE WATER FOR INJECTION | Medefil, Inc. | 99e99a50-82d5-aff6-e053-2a95a90a8c56 | 2025-01-08 | Warnings, Adverse reactions | 059QF0KO0R |
| BACTERIOSTATIC WATER | BACTERIOSTATIC WATER | HF Acquisition Co LLC, DBA HealthFirst | 99b0ef9b-600a-40dc-e053-2a95a90aa07e | 2025-01-08 | Warnings, Adverse reactions | 059QF0KO0R |
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 99b1cb12-0b2d-0c0f-e053-2a95a90ac3b6 | 2025-01-08 | Warnings, Adverse reactions | 059QF0KO0R |
| Zemdri (plazomicin) | PLAZOMICIN | Cipla USA Inc. | eccf9fd9-53ac-4252-a106-5567b3a82a70 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | NDA210303 2049558 2049553 LYO9XZ250J |
| Fendall Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | afda6fc3-7615-b0be-e053-2995a90a6208 | 2024-12-10 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
| Crane Safety Eye Wash | WATER SOLUTION | Crane Safety LLC | 96d8dda9-6cd6-3f68-e053-2995a90a0da2 | 2024-11-08 | Warnings | 059QF0KO0R |
| RUGBY EYE WASH | WATER, PURIFIED | A-S Medication Solutions | 0773e558-2f46-494c-888a-3bc517202b65 | 2024-11-08 | Warnings | 059QF0KO0R |
| EyS Eye Wash | WATER | Eyes-Plus LLC | 1443f6bf-3a77-4a19-8585-0ec58efe042f | 2024-10-15 | Warnings | 059QF0KO0R |
| Eye Wash | WATER SOLUTION | Kroger Company | 354402ad-581d-47e7-9fd3-933bef281ff4 | 2024-10-11 | Warnings | 059QF0KO0R |
| Eye Wash | WATER | Hubei Changjian Medical Products Co., Ltd. | d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea | 2024-10-11 | Warnings | 059QF0KO0R |
| Empathy | AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA | Deseret Biologicals, Inc. | a89067c1-ef12-49da-8fa6-e65ff664f497 | 2024-08-13 | Warnings | 059QF0KO0R |
| Thompson Safety Eyewash | WATER | Thompson Safety | 1d0e96cf-245b-cfb7-e063-6294a90a4ced | 2024-07-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | ad42a7e3-84ea-390d-e053-2a95a90a3a32 | 2024-06-14 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.