Medicine
Protamine 50 mg/5 mL injection
Protamine 50 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 2 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
Do not permit to freeze. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Protamine
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 5 mL, 5 mL, 25 pouches of 5 mL and 3 more
- Manufacturers
- Fresenius KabiHealthFirst
- Origin register
- US FDA, United States
- Storage
- Do not permit to freeze. Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V03AB14 Protamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 October 2000
- Identifiers
- RxCUI 1796672, 1796676DailyMed set ID 94d4f57f-940e-c0a8-e053-2a95a90ae3af, c76876da-b9a8-45d0-9278-7df3288d3a06, 8df0a819-9e1a-44ce-97a6-3ea82c867d44 +2NDC 51662-1414, 65219-646, 63323-229Application ANDA089454
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 |
|---|---|---|---|
| 25 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 63323-229-05 | Fresenius Kabi | 18 October 2000 |
| 25 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 63323-229-15 | Fresenius Kabi | 18 October 2000 |
| 25 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 63323-229-94 | Fresenius Kabi | 18 October 2000 |
| 25 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 65219-646-05 | Fresenius Kabi | 28 March 2025 |
| 5 mL in 1 vial, single-dose | 51662-1414-1 | HealthFirst | 13 October 2019 |
| 25 pouch in 1 case / 1 vial, single-dose in 1 pouch / 5 mL in 1 vial, single-dose | 51662-1414-3 | HealthFirst | 16 June 2023 |
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 13 August 1969 | 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 Protamine
Clinical summary
Protamine is a heparin reversal agent indicated in the treatment of heparin overdosage. It is available as injection for intravenous use. MedsAcross supplies Protamine 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 ProtamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Protamine Sulfate prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Protamine 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.