Medicine
Cilastatin and Imipenem 250 mg/250 mg per 20 mL powder for injection
Cilastatin and Imipenem 250 mg/250 mg per 20 mL powder for injection is a generic prescription medicine for intravenous use, 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
Before Reconstitution: Imipenem and Cilastatin for Injection, USP (I.V.)…
Key facts
- Active ingredient (INN)
- Cilastatin and Imipenem
- Brand
- Sold under the generic name
- Strength
- 250 mg/250 mg per 20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 25 vials
- Manufacturer
- Fresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Before Reconstitution: Imipenem and Cilastatin for Injection, USP (I.V.) sterile powder should be stored at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 January 2012
- Identifiers
- RxCUI 1726204DailyMed set ID 0a1dd9b9-ada1-4bff-9dcb-18961254e9e8, ce771566-c4f2-447e-944a-6b908925c90b, 6ab0ca9e-9a79-4cab-9f09-470eda06952eNDC 63323-349Application ANDA090577
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 |
|---|---|---|---|
| 25 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 63323-349-25 | Fresenius Kabi | 3 January 2012 |
| 25 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 63323-349-93 | Fresenius Kabi | 3 January 2012 |
| 25 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 63323-349-94 | Fresenius Kabi | 3 January 2012 |
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 26 November 1985 | 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 Cilastatin and Imipenem
Clinical summary
Cilastatin and Imipenem is a fixed-dose combination of a penem antibacterial and a renal dehydropeptidase inhibitor indicated for the treatment of serious infections caused by designated susceptible bacteria, among other approved uses. MedsAcross supplies Cilastatin and Imipenem 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 Cilastatin and ImipenemFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PRIMAXIN IV prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
Need Cilastatin and Imipenem 250 mg/250 mg per 20 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.