Medicine
Phenylephrine 50 mg/5 mL injection
Phenylephrine 50 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 21 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
Store phenylephrine hydrochloride injection, USP 10 mg/mL at 20°C to 25°C…
Key facts
- Active ingredient (INN)
- Phenylephrine
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 5 mL, 1 vial of 5 mL and 21 more
- Manufacturers
- Caplin SterilesIndiaCamber PharmaceuticalsIndiaEugiaIndiaGland PharmaIndiaLifestar PharmaIndiaNovadoz PharmaceuticalsIndiaSandozSomerset TherapeuticsAmneal PharmaceuticalsArmas Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store phenylephrine hydrochloride injection, USP 10 mg/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. Store in carton until time of use. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions.
- 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
- 27 April 2018
- Identifiers
- RxCUI 1232651, 1666372, 2262018 +3DailyMed set ID 6feb2da2-05ef-47bb-9d8d-01b81ad69059, 4bab505d-d5c8-8c3b-e063-6394a90ad18a, 90a3853e-49d6-4536-be72-82cc875bcf74 +20NDC 0781-3458, 58657-852, 70069-802 +20Application ANDA208905, ANDA218412, ANDA213318 +13
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, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 31722-344-31 | Camber PharmaceuticalsIndia | 10 May 2024 |
| 1 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 65145-116-01 | Caplin SterilesIndia | 28 April 2026 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 65145-116-10 | Caplin SterilesIndia | 28 April 2026 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 55150-301-10 | EugiaIndia | 13 November 2020 |
| 10 vial in 1 carton / 5 mL in 1 vial | 68083-338-10 | Gland PharmaIndia | 21 October 2020 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 70756-622-10 | Lifestar PharmaIndia | 31 August 2022 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 72205-265-07 | Novadoz PharmaceuticalsIndia | 4 May 2024 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 0781-3458-95 | Sandoz | 15 January 2020 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 0781-9227-95 | Sandoz | 17 February 2021 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 70069-802-10 | Somerset Therapeutics | 22 September 2021 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 70069-812-10 | Somerset Therapeutics | 17 July 2023 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 70121-1578-7 | Amneal Pharmaceuticals | 24 July 2018 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 72485-505-10 | Armas Pharmaceuticals | 28 March 2023 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 36000-360-10 | Baxter Healthcare | 6 April 2026 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 71839-128-10 | BE Pharmaceuticals | 10 July 2023 |
| 1 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 63323-751-05 | Fresenius Kabi | 25 May 2019 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 14335-441-01 | Hainan Poly Pharm | 19 March 2024 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 0641-6188-10 | Hikma Pharmaceuticals | 19 June 2019 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 71288-808-76 | Meitheal Pharmaceuticals | 27 April 2018 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 58657-852-11 | Method Pharmaceuticals | 1 February 2026 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 42023-214-10 | Par Health | 17 July 2019 |
| 10 vial in 1 carton / 5 mL in 1 vial | 81284-212-10 | Provepharm | 12 August 2020 |
| 10 vial in 1 carton / 5 mL in 1 vial | 25021-315-99 | Sagent Pharmaceuticals | 15 October 2020 |
| 10 vial, pharmacy bulk package in 1 carton / 5 mL in 1 vial, pharmacy bulk package | 70594-064-02 | Xellia Pharmaceuticals | 1 January 2022 |
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
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 50 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.