Medicine
Ertapenem 1 g powder for injection
Ertapenem 1 g powder for injection is a generic prescription medicine for intramuscular, intravenous use, made by 11 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
Before reconstitution Do not store lyophilized powder above 25°C (77°F)…
Key facts
- Active ingredient (INN)
- Ertapenem
- Brand
- Sold under the generic name
- Strength
- 1 g
- Dosage form
- Powder for injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials, 5 vials and 12 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaGland PharmaIndiaEndoFosun PharmaHikma PharmaceuticalsSagent PharmaceuticalsFresenius KabiHospiraNorthStar RxLLCQilu Antibiotics Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Before reconstitution Do not store lyophilized powder above 25°C (77°F). Reconstituted and infusion solutions The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection, may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01DH03 Ertapenem
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 July 2018
- Identifiers
- RxCUI 1734683DailyMed set ID b88c0709-33fe-47db-8ae8-8bad6692d5d5, 2398d418-6efc-b4d2-3265-936001df9b8b, 124775ed-1271-4581-be52-b7a08c91283d +11NDC 0143-9429, 16714-889, 25021-199 +9Application ANDA218067, ANDA212040, NDA021337 +1
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 43598-901-58 | Dr. Reddy's LaboratoriesIndia | 29 April 2021 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 68083-351-10 | Gland PharmaIndia | 26 March 2021 |
| 10 vial, single-dose in 1 package / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 42023-221-10 | Endo | 26 July 2018 |
| 10 vial, single-dose in 1 package / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 42023-221-85 | Endo | 1 November 2018 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 0143-9398-10 | Hikma Pharmaceuticals | 2 August 2021 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 0143-9429-10 | Hikma Pharmaceuticals | 28 February 2025 |
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 25021-199-20 | Sagent Pharmaceuticals | 15 August 2025 |
| 10 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial | 25021-199-66 | Sagent Pharmaceuticals | 15 January 2026 |
| 5 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 72266-159-05 | Fosun Pharma | 9 December 2022 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 72266-159-10 | Fosun Pharma | 1 November 2021 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 63323-823-20 | Fresenius Kabi | 10 October 2019 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 0409-3510-22 | Hospira | 19 October 2020 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 51810-504-02 | Qilu Antibiotics Pharmaceutical | 31 October 2024 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 44567-820-10 | WG Critical Care | 7 January 2020 |
| 10 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 16714-889-10 | NorthStar RxLLC | 13 July 2021 |
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.
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 Ertapenem 1 g powder for injection.
Other strengths and forms of Ertapenem
Clinical summary
Ertapenem is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of moderate to severe infections caused by susceptible bacteria, among other approved uses. MedsAcross supplies Ertapenem 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 ErtapenemFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ERTAPENEM prescribing information (Endo) · U.S. National Library of Medicine, DailyMed
- Invanz: European public assessment report (EPAR) · European Medicines Agency
- Ertapenem SUN: European public assessment report (EPAR) · European Medicines Agency
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