Medicine
Ampicillin and Sulbactam 1 g/0.5 g per 1.5 g powder for injection
Ampicillin and Sulbactam 1 g/0.5 g per 1.5 g 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
The following packages are available: Single-dose vials containing 1.5 g (NDC…
Key facts
- Active ingredient (INN)
- Ampicillin and Sulbactam
- Brand
- Sold under the generic name
- Strength
- 1 g/0.5 g per 1.5 g
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials
- Manufacturer
- Hikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- The following packages are available: Single-dose vials containing 1.5 g (NDC 0641-6116-10) equivalent of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) Single-dose vials containing 3 g (NDC 0641-6117-10) equivalent of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the…
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.10Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 December 2009
- Identifiers
- RxCUI 1659592, 1659598DailyMed set ID d3026cc0-95d8-44cf-be47-b5ebb8fd4568NDC 0641-6116, 0641-6117Application ANDA065406
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 in 1 carton / 1.5 g in 1 vial | 0641-6116-10 | Hikma Pharmaceuticals | 22 December 2009 |
| 10 vial in 1 carton / 3 g in 1 vial | 0641-6117-10 | Hikma Pharmaceuticals | 22 December 2009 |
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 31 December 1986 | 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 Ampicillin and Sulbactam
Clinical summary
Ampicillin and Sulbactam is a fixed-dose combination of a penicillin-class antibacterial and a beta lactamase inhibitor indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. MedsAcross supplies Ampicillin and Sulbactam 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 Ampicillin and SulbactamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- UNASYN prescribing information (Roerig) · U.S. National Library of Medicine, DailyMed
Need Ampicillin and Sulbactam 1 g/0.5 g per 1.5 g 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.