Medicine
Nuzyra 100 mg/5 mL powder for injection
Nuzyra 100 mg/5 mL powder for injection is a prescription medicine containing Omadacycline for intravenous use, marketed by Paratek Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. NUZYRA for Injection and NUZYRA Tablets should be stored at…
Key facts
- Active ingredient (INN)
- Omadacycline
- Brand
- Nuzyra
- Strength
- 100 mg/5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials
- Marketing authorisation holder
- Paratek Pharmaceuticals
- Manufacturer
- Paratek Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. NUZYRA for Injection and NUZYRA Tablets should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01AA15 Omadacycline
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 February 2019
- Identifiers
- RxCUI 2059274, 2059280, 2059288 +1DailyMed set ID 51591524-4703-44c6-8bde-dce3e6a463d1NDC 71715-001Application NDA209817
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 71715-001-02 | Paratek Pharmaceuticals | 1 February 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 2 October 2018 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Omadacycline
Clinical summary
Omadacycline is a tetracycline-class antibacterial indicated for the treatment of adult patients with infections caused by susceptible microorganisms, among other approved uses. It is available as powder for injection and tablets for intravenous and oral use. MedsAcross supplies Omadacycline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about OmadacyclineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- NUZYRA prescribing information (Paratek Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Nuzyra 100 mg/5 mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.