Medicine
Heparin 5000 units/mL injection
Heparin 5000 units/mL injection is a generic prescription medicine for intravenous, subcutaneous use, made by 17 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 between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Heparin
- Brand
- Sold under the generic name
- Strength
- 5000 units/mL
- Dosage form
- Injection
- Route
- Intravenous, subcutaneous
- Packs
- 25 vials, 24 blister pack, 10 syringes and 29 more
- Manufacturers
- Gland PharmaIndiaCardinal HealthFresenius KabiMeitheal PharmaceuticalsSagent PharmaceuticalsHepalinkHikma PharmaceuticalsHospiraNorthStar RxLLCSandoz17 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AB01 Heparin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 February 1972
- Identifiers
- RxCUI 1361226, 1361615, 1658637 +7DailyMed set ID c4fa6d34-e76b-4c3c-b74d-21ce41432a04, ed937dd2-8fab-4875-a1e8-627b71ccb7fb, 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 +23NDC 72603-214, 63323-262, 0641-6199 +26Application ANDA211007, NDA017029, NDA017037 +10
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 in 1 carton / 1 mL in 1 vial | 68083-136-25 | Gland PharmaIndia | 9 March 2017 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-262-06 | Fresenius Kabi | 25 March 2020 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-262-26 | Fresenius Kabi | 25 March 2020 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-262-36 | Fresenius Kabi | 2 March 2020 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 76045-108-10 | Fresenius Kabi | 10 June 2016 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 71288-403-02 | Meitheal Pharmaceuticals | 15 June 2019 |
| 25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 71288-403-11 | Meitheal Pharmaceuticals | 15 June 2019 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 71288-406-82 | Meitheal Pharmaceuticals | 15 July 2020 |
| 25 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 71288-450-02 | Meitheal Pharmaceuticals | 2 July 2025 |
| 25 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 81952-111-06 | Hepalink | 12 June 2014 |
| 25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 81952-114-09 | Hepalink | 12 June 2014 |
| 25 vial in 1 package / 1 mL in 1 vial | 0641-0400-12 | Hikma Pharmaceuticals | 22 March 1972 |
| 10 syringe, glass in 1 carton / 1 mL in 1 syringe, glass | 0641-6199-10 | Hikma Pharmaceuticals | 19 May 2019 |
| 25 vial in 1 carton / 1 mL in 1 vial | 25021-402-01 | Sagent Pharmaceuticals | 6 July 2010 |
| 25 vial in 1 carton / 10 mL in 1 vial | 25021-402-10 | Sagent Pharmaceuticals | 6 July 2010 |
| 25 vial in 1 carton / 1 mL in 1 vial | 25021-402-66 | Sagent Pharmaceticals | 1 July 2014 |
| 25 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 0781-3545-25 | Sandoz | 16 September 2024 |
| 25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 0781-3550-25 | Sandoz | 16 September 2024 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 0409-2723-01 | Hospira | 31 August 2009 |
| 25 vial, multi-dose in 1 tray / 10 mL in 1 vial, multi-dose | 0409-2723-02 | Hospira | 31 August 2009 |
| 25 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 87188-102-90 | Plano Pharmaceuticals | 8 December 2016 |
| 5 vial in 1 bag / 1 mL in 1 vial | 55154-2827-5 | Cardinal Health | 6 July 2010 |
| 5 vial in 1 bag / 1 mL in 1 vial | 55154-5130-5 | Cardinal Health | 22 March 1972 |
| 5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 55154-6985-5 | Cardinal Health | 31 August 2009 |
| 5 vial in 1 bag / 1 mL in 1 vial | 55154-9585-5 | Cardinal Health | 25 March 2020 |
| 25 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 72603-214-25 | NorthStar RxLLC | 1 April 2024 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 72603-412-25 | NorthStar RxLLC | 1 April 2024 |
| 25 vial in 1 package / 1 mL in 1 vial | 72572-255-25 | Civica | 15 November 2019 |
| 1 mL in 1 cartridge | 51662-1460-1 | HealthFirst | 22 December 2019 |
| 1 vial in 1 bag / 1 mL in 1 vial | 0404-9872-01 | Henry Schein | 11 January 2022 |
| 25 vial, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 72603-456-25 | Northstar Rx | 1 March 2025 |
| 25 vial in 1 package / 1 mL in 1 vial | 70518-4547-0 | Remedyrepack | 16 January 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 9 February 1939 | 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 Heparin
Clinical summary
Heparin is an anti-coagulant indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism,, among other approved uses. It is available as injection for intravenous and subcutaneous use. MedsAcross supplies Heparin 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 HeparinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Heparin Sodium prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Heparin 5000 units/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.