Medicine
Piperacillin and Tazobactam 4 g/0.5 g per 20 mL powder for injection
Piperacillin and Tazobactam 4 g/0.5 g per 20 mL powder for injection is a generic prescription medicine for intravenous use, made by 10 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
Piperacillin and Tazobactam for Injection, USP vials should be stored at…
Key facts
- Active ingredient (INN)
- Piperacillin and Tazobactam
- Brand
- Sold under the generic name
- Strength
- 4 g/0.5 g per 20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials, 1 bottle, 1 vial and 51 more
- Manufacturers
- Fresenius KabiProvepharmApotexShandong Anxin PharmaceuticalOnesource Specialty PharmaArmas Pharmaceuticals10 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Piperacillin and Tazobactam for Injection, USP vials should be stored at controlled room temperature (20°C to 25°C [68°F to 77°F]) prior to reconstitution.
- 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
- 13 October 2009
- Identifiers
- RxCUI 1659131, 1659137, 1659149 +1DailyMed set ID bc26ffd8-1a6e-4e16-91c1-ec67c928b3bf, 420196a5-f62d-473f-84d8-d7fc3f31c3d3, 2c8f06a2-49b2-4169-94ef-182d13d248bf +24NDC 81284-151, 35369-0502, 60505-6156 +37Application ANDA207847, ANDA204959, ANDA065523 +6
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
A sample of 40 packs from 10 labelers. The register lists 54 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial in 1 box / 15 mL in 1 vial | 63323-300-30 | Fresenius Kabi | 13 October 2009 |
| 10 vial in 1 box / 15 mL in 1 vial | 63323-300-36 | Fresenius Kabi | 13 October 2009 |
| 1 bottle in 1 carton / 180 mL in 1 bottle | 63323-304-74 | Fresenius Kabi | 31 May 2011 |
| 1 bottle in 1 carton / 180 mL in 1 bottle | 63323-304-78 | Fresenius Kabi | 31 May 2011 |
| 1 bottle in 1 carton / 180 mL in 1 bottle | 63323-304-94 | Fresenius Kabi | 31 May 2011 |
| 10 vial in 1 box / 10 mL in 1 vial | 63323-309-20 | Fresenius Kabi | 13 October 2009 |
| 10 vial in 1 box / 10 mL in 1 vial | 63323-309-26 | Fresenius Kabi | 13 October 2009 |
| 10 vial in 1 box / 20 mL in 1 vial | 63323-320-50 | Fresenius Kabi | 13 October 2009 |
| 10 vial in 1 box / 20 mL in 1 vial | 63323-320-56 | Fresenius Kabi | 13 October 2009 |
| 10 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 63323-981-21 | Fresenius Kabi | 18 May 2018 |
| 10 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 63323-981-53 | Fresenius Kabi | 18 May 2018 |
| 10 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 63323-982-52 | Fresenius Kabi | 18 May 2018 |
| 10 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 63323-982-54 | Fresenius Kabi | 18 May 2018 |
| 10 vial, single-use in 1 carton / 15 mL in 1 vial, single-use | 63323-983-21 | Fresenius Kabi | 18 May 2018 |
| 10 vial, single-use in 1 carton / 15 mL in 1 vial, single-use | 63323-983-53 | Fresenius Kabi | 18 May 2018 |
| 1 vial, pharmacy bulk package in 1 carton / 180 mL in 1 vial, pharmacy bulk package | 65219-256-00 | Fresenius Kabi | 16 November 2017 |
| 1 vial, pharmacy bulk package in 1 carton / 180 mL in 1 vial, pharmacy bulk package | 65219-256-24 | Fresenius Kabi | 16 November 2017 |
| 1 vial, pharmacy bulk package in 1 carton / 180 mL in 1 vial, pharmacy bulk package | 65219-256-28 | Fresenius Kabi | 16 November 2017 |
| 10 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 65219-259-45 | Fresenius Kabi | 18 May 2018 |
| 10 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 65219-259-55 | Fresenius Kabi | 24 May 2021 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 65219-434-20 | Fresenius Kabi | 20 March 2023 |
| 10 vial, single-dose in 1 carton / 15 mL in 1 vial, single-dose | 65219-436-20 | Fresenius Kabi | 20 March 2023 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 81284-151-10 | Provepharm | 1 August 2019 |
| 10 vial, single-dose in 1 carton / 15 mL in 1 vial, single-dose | 81284-152-10 | Provepharm | 1 August 2019 |
| 10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 81284-153-10 | Provepharm | 1 August 2019 |
| 1 vial, pharmacy bulk package in 1 carton / 60 mL in 1 vial, pharmacy bulk package | 81284-154-01 | Provepharm | 11 January 2023 |
| 1 vial, pharmacy bulk package in 1 carton / 180 mL in 1 vial, pharmacy bulk package | 81284-155-01 | Provepharm | 1 August 2019 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 60505-6156-4 | Apotex | 15 March 2019 |
| 10 vial, single-dose in 1 carton / 15 mL in 1 vial, single-dose | 60505-6157-4 | Apotex | 15 March 2019 |
| 10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 60505-6159-4 | Apotex | 15 March 2019 |
| 1 vial, pharmacy bulk package in 1 carton / 180 mL in 1 vial, pharmacy bulk package | 60505-6262-0 | Apotex | 26 September 2023 |
| 10 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 35369-0501-2 | Shandong Anxin Pharmaceutical | 10 August 2018 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 35369-0502-2 | Shandong Anxin Pharmaceutical | 10 August 2018 |
| 10 vial, single-dose in 1 carton / 15 mL in 1 vial, single-dose | 35369-0503-2 | Shandong Anxin Pharmaceutical | 10 August 2018 |
| 1 vial, pharmacy bulk package in 1 carton / 180 mL in 1 vial, pharmacy bulk package | 35369-0504-1 | Shandong Anxin Pharmaceutical | 14 April 2023 |
| 10 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 83270-301-10 | Onesource Specialty Pharma | 30 June 2016 |
| 10 vial, single-use in 1 carton / 15 mL in 1 vial, single-use | 83270-302-10 | Onesource Specialty Pharma | 14 August 2015 |
| 10 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 83270-303-10 | Onesource Specialty Pharma | 30 June 2016 |
| 10 vial, single-dose in 1 box / 15 mL in 1 vial, single-dose | 72485-403-10 | Armas Pharmaceuticals | 14 April 2022 |
| 20 vial, single-dose in 1 box / 15 mL in 1 vial, single-dose | 72485-403-20 | Armas Pharmaceuticals | 22 October 2026 |
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 22 October 1993 | 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 Piperacillin and Tazobactam
Clinical summary
Piperacillin and Tazobactam is a fixed-dose combination of a penicillin-class antibacterial and a beta lactamase inhibitor indicated for the treatment of intra-abdominal infections in adult and pediatric patients 2 months of age and older. MedsAcross supplies Piperacillin and Tazobactam 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 Piperacillin and TazobactamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zosyn prescribing information (Baxter Healthcare) · U.S. National Library of Medicine, DailyMed
Need Piperacillin and Tazobactam 4 g/0.5 g 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.