Medicine
Phenylephrine 0.5 mg/5 mL injection
Phenylephrine 0.5 mg/5 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
Store phenylephrine hydrochloride injection USP, 500 mcg/5 mL (100 mcg/mL), at…
Key facts
- Active ingredient (INN)
- Phenylephrine
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 ampules of 5 mL
- Manufacturer
- Somerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store phenylephrine hydrochloride injection USP, 500 mcg/5 mL (100 mcg/mL), 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.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01CA06 Phenylephrine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 March 2025
- Identifiers
- RxCUI 2262018DailyMed set ID 170e63f1-23f4-4839-ab89-b81832d94a56NDC 70069-591Application ANDA215617
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 ampule in 1 carton / 5 mL in 1 ampule | 70069-591-10 | Somerset Therapeutics | 4 March 2025 |
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 20 December 2012 | 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 Phenylephrine 0.5 mg/5 mL injection.
Other strengths and forms of Phenylephrine
Clinical summary
Phenylephrine is an alpha-1 adrenergic agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia, among other approved uses. MedsAcross supplies Phenylephrine 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 PhenylephrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Phenylephrine Hydrochloride prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Phenylephrine 0.5 mg/5 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.