Prescription drug · NDA
Zemdri (plazomicin) (Plazomicin) NDC 71045-010
Plazomicin 500 mg/10mL · Injection · Intravenous · Achaogen, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71045-010-02 | 71045001002 | 10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01)Marketed from Jul 16, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zemdri (plazomicin)
- Generic name (nonproprietary)
- plazomicin
- Active ingredients
- Plazomicin — 500 mg/10mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Achaogen, Inc.NDC labeler code 71045
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210303
- Marketing start
- Listing expires
- Identifiers
- Product ID 71045-010_7803b863-697d-4d96-911f-5a229bbd8272SPL ID 7803b863-697d-4d96-911f-5a229bbd8272SPL set ID 0b82ffed-27f4-4f5c-8135-670c148f0e12RxCUI 2049553, 2049558UNII LYO9XZ250J
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471045001002followed by a unit qualifier and the quantityPackage 71045-0010-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
1. INDICATIONS AND USAGE ZEMDRI is an aminoglycoside antibacterial indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. ( 1.1 ) As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain effectiveness of ZEMDRI and other antibacterial drugs, ZEMDRI should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms. ( 1.2 ) 1.1 Complicated Urinary Tract Infections (cUTI), including Pyelon…
Excerpt only. Read the full label for complete information.
About NDC 71045-010
- What is NDC 71045-010?
- 71045-010 is the product NDC for Zemdri (plazomicin) (plazomicin), Plazomicin 500 mg/10mL injection, listed with the FDA by Achaogen, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zemdri (plazomicin) (Plazomicin).
- What is the active ingredient?
- Plazomicin.
- Who is the labeler?
- Achaogen, Inc., NDC labeler code 71045. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zemdri (plazomicin)?
- 2 other product NDCs are listed under this name. See all Zemdri (plazomicin) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zemdri (plazomicin) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zemdri (plazomicin)plazomicin | Plazomicin 500 mg/10mL | InjectionIntravenous | Cipla USA Inc. | 69097-820 | 69097-0820-96 |
| Zemdri (plazomicin)plazomicin | Plazomicin 500 mg/10mL | InjectionIntravenous | Cipla Therapeutics Inc. | 80735-820 | 80735-0820-96 |
Other NDCs under NDA 210303
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zemdri (plazomicin)plazomicin | Plazomicin 500 mg/10mL | InjectionIntravenous | Cipla USA Inc. | 69097-820 |
| Zemdri (plazomicin)plazomicin | Plazomicin 500 mg/10mL | InjectionIntravenous | Cipla Therapeutics Inc. | 80735-820 |