Medicine
Cysteine 345 mg/10 mL injection
Cysteine 345 mg/10 mL 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
Protect from freezing. Store cysteine hydrochloride injection, USP at 20°C to…
Key facts
- Active ingredient (INN)
- Cysteine
- Brand
- Sold under the generic name
- Strength
- 345 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 vials of 10 mL
- Manufacturer
- Baxter Healthcare
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store cysteine hydrochloride injection, USP at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. For storage of admixed solution see Dosage and Administration
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 April 2022
- Identifiers
- DailyMed set ID cbf70fc3-14b3-4c17-8de8-acba1e12ac95NDC 0338-9645Application NDA212535
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 |
|---|---|---|---|
| 5 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0338-9645-01 | Baxter Healthcare | 29 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 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 Cysteine
Clinical summary
Cysteine is a prescription medicine indicated as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN), and of adult and pediatric patients with severe liver disease. MedsAcross supplies Cysteine 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 CysteineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ELCYS prescribing information (Exela Pharma Sciences) · U.S. National Library of Medicine, DailyMed
Need Cysteine 345 mg/10 mL 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.