Prescription drug · NDA
Nuzyra (Omadacycline) NDC 71715-001
Omadacycline 100 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Paratek Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71715-001-02 | 71715000102 | 10 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01)Marketed from Feb 1, 2019 |
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)
- Nuzyra
- Generic name (nonproprietary)
- omadacycline
- Active ingredients
- Omadacycline — 100 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Paratek Pharmaceuticals, Inc.NDC labeler code 71715
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209817
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 71715-001_52cb2b5d-4a13-8b4a-e063-6294a90ad5b1SPL ID 52cb2b5d-4a13-8b4a-e063-6294a90ad5b1SPL set ID 51591524-4703-44c6-8bde-dce3e6a463d1RxCUI 2059274, 2059280, 2059288, 2059292UNII 090IP5RV8FUPC 0371715001027, 0371715002215, 0371715002277
- Pharmacologic class
- Tetracycline-class Antibacterial
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
N471715000102followed by a unit qualifier and the quantityPackage 71715-0001-02. 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 .
Indications (excerpt from the label)
NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms ( 1 ): Community-acquired bacterial pneumonia (CABP) ( 1.1 ) Acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 ) 1.1 Community-Acquired Bacterial Pneumonia NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused b…
Excerpt only. Read the full label for complete information.
About NDC 71715-001
- What is NDC 71715-001?
- 71715-001 is the product NDC for Nuzyra (omadacycline), Omadacycline 100 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Paratek Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nuzyra (Omadacycline).
- What is the active ingredient?
- Omadacycline.
- Who is the labeler?
- Paratek Pharmaceuticals, Inc., NDC labeler code 71715. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nuzyra?
- 1 other product NDC are listed under this name. See all Nuzyra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nuzyra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nuzyraomadacycline | Omadacycline 150 mg/1 | Tablet, Film coatedOral | Paratek Pharmaceuticals, Inc. | 71715-002 | 71715-0002-2171715-0002-27 |