Medicine
Phenylephrine 10 mg/1 mL injection
Phenylephrine 10 mg/1 mL injection is a generic prescription medicine for intravenous use, made by 28 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Phenylephrine
- Brand
- Sold under the generic name
- Strength
- 10 mg/1 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 1 mL, 10 vials of 1 mL, 1 vial of 1 mL and 39 more
- Manufacturers
- Camber PharmaceuticalsIndiaAvet PharmaceuticalsIndiaCaplin SterilesIndiaEugiaIndiaGland PharmaIndiaLifestar PharmaIndiaNovadoz PharmaceuticalsIndiaMedical Purchasing SolutionsHealthFirstFresenius Kabi28 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° 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
- 18 December 2012
- Identifiers
- RxCUI 1666372, 1232651, 2262018 +3DailyMed set ID c600fe14-40b6-2b5a-e053-2a95a90aff98, abd39d9c-fcda-4d01-8a58-1d54ba7ac651, e1a7ab4b-0afe-4463-a039-5be0323cf2f7 +36NDC 51662-1576, 70594-063, 0641-6142 +35Application ANDA210665, ANDA213318, NDA203826 +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
A sample of 40 packs from 28 labelers. The register lists 42 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial in 1 carton / 1 mL in 1 vial | 23155-620-41 | Avet PharmaceuticalsIndia | 28 February 2023 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 31722-343-32 | Camber PharmaceuticalsIndia | 10 May 2024 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 31722-343-33 | Camber PharmaceuticalsIndia | 10 May 2024 |
| 25 vial in 1 carton / 1 mL in 1 vial | 65145-115-25 | Caplin SterilesIndia | 28 April 2026 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 55150-300-25 | EugiaIndia | 7 January 2021 |
| 25 vial in 1 carton / 1 mL in 1 vial | 68083-465-25 | Gland PharmaIndia | 14 April 2021 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70756-621-25 | Lifestar PharmaIndia | 31 August 2022 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 72205-264-25 | Novadoz PharmaceuticalsIndia | 4 May 2024 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 63323-751-01 | Fresenius Kabi | 25 May 2019 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 63323-751-13 | Fresenius Kabi | 25 May 2019 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 65219-388-01 | Fresenius Kabi | 10 May 2026 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-6142-25 | Hikma Pharmaceuticals | 18 December 2012 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-6229-25 | Hikma Pharmaceuticals | 18 December 2012 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 0781-3422-92 | Sandoz | 16 December 2019 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 0781-9226-92 | Sandoz | 17 February 2021 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70069-801-25 | Somerset Therapeutics | 22 September 2021 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70069-811-25 | Somerset Therapeutics | 17 July 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 70121-1577-5 | Amneal Pharmaceuticals | 7 July 2018 |
| 25 vial in 1 carton / 1 mL in 1 vial | 72485-504-25 | Armas Pharmaceuticals | 28 March 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 36000-358-25 | Baxter Healthcare | 6 April 2026 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 71839-127-25 | BE Pharmaceuticals | 10 July 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 14335-440-01 | Hainan Poly Pharm | 19 March 2024 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7303-1 | Medical Purhasing Solutions | 9 June 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 71288-807-02 | Meitheal Pharmaceuticals | 27 April 2018 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 58657-851-26 | Method Pharmaceuticals | 1 February 2026 |
| 25 vial in 1 carton / 1 mL in 1 vial | 81284-211-25 | Provepharm | 12 August 2020 |
| 25 vial in 1 carton / 1 mL in 1 vial | 25021-315-01 | Sagent Pharmaceuticals | 15 October 2020 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70594-063-02 | Xellia Pharmaceuticals | 1 January 2022 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7043-1 | Medical Purchasing Solutions | 25 October 2021 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 71872-7159-1 | Medical Purchasing Solutions | 9 April 2019 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 71872-7267-1 | Medical Purchasing Solutions | 20 September 2021 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7273-1 | Medical Purchasing Solutions | 10 December 2021 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 71872-7343-1 | Medical Purchasing Solutions | 20 January 2025 |
| 1 vial in 1 bag / 1 mL in 1 vial | 71872-7348-1 | Medical Purchasing Solutions | 21 April 2025 |
| 1 mL in 1 vial, single-dose | 51662-1249-1 | HealthFirst | 16 September 2018 |
| 25 pouch in 1 case / 1 mL in 1 pouch | 51662-1249-3 | HealthFirst | 29 April 2020 |
| 1 mL in 1 vial, single-dose | 51662-1576-1 | HealthFirst | 30 June 2021 |
| 25 pouch in 1 case / 1 vial, single-dose in 1 pouch / 1 mL in 1 vial, single-dose | 51662-1576-3 | HealthFirst | 10 July 2022 |
| 5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 55154-8226-5 | Cardinal Health | 7 July 2018 |
| 25 vial in 1 carton / 1 mL in 1 vial | 72572-571-25 | Civica | 2 December 2020 |
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 10 mg/1 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 10 mg/1 mL injection for your hospital or patient?
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