Medicine
Ampicillin and Sulbactam 100 mg/50 mg per mL powder for injection
Ampicillin and Sulbactam 100 mg/50 mg per mL powder for injection is a generic prescription medicine for intravenous use, made by 3 labelers, 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
Conditions Prior to reconstitution, store dry powder at 20° to 25°C (68° to…
Key facts
- Active ingredient (INN)
- Ampicillin and Sulbactam
- Brand
- Sold under the generic name
- Strength
- 100 mg/50 mg per mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial, 100 mL, 1 bottle and 1 more
- Manufacturers
- EugiaIndiaHikma PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Conditions Prior to reconstitution, store dry powder 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)
- 3004.10Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 December 2009
- Identifiers
- RxCUI 240984DailyMed set ID 35606b43-5914-423c-9bc7-fa3957eb2563, 437a26f4-776b-4f74-99b2-09ad79831b0c, 2709e9fc-2341-4382-af72-c2e3201bd77a +1NDC 25021-144, 55150-118, 0641-6118Application ANDA065403, ANDA090339
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 55150-118-01 | EugiaIndia | 10 February 2012 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 55150-118-99 | EugiaIndia | 10 February 2012 |
| 100 mL in 1 vial, pharmacy bulk package | 0641-6118-01 | Hikma Pharmaceuticals | 3 December 2009 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 25021-144-99 | Sagent Pharmaceuticals | 12 August 2010 |
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
Alternatives
Other makers and brands of Ampicillin and Sulbactam 100 mg/50 mg per mL powder for injection.
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 100 mg/50 mg per 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.