Medicine
Heparin 5000 units/100 mL injection
Heparin 5000 units/100 mL injection is a generic prescription medicine for intravenous use, made by 3 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
Protect from freezing. Store at 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Heparin
- Brand
- Sold under the generic name
- Strength
- 5000 units/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 24 bags, 30 pouches, 20 pouches and 2 more
- Manufacturers
- Fresenius KabiHospiraB. Braun Medical
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20°C to 25°C (68°F to 77°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
- 24 August 2017
- Identifiers
- RxCUI 1658717, 1659195, 1659196 +1DailyMed set ID 0413f511-6b34-4c15-e48b-3fad08baacbe, cb1c1e7a-c9ca-4a07-8833-e45ce436d287, 8b030692-fc66-4c53-85aa-6f865e635618NDC 0409-0012, 63323-518, 0409-3150 +2Application NDA018916, NDA017029, NDA019953
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 |
|---|---|---|---|
| 24 bag in 1 case / 500 mL in 1 bag | 63323-518-77 | Fresenius Kabi | 24 August 2017 |
| 24 bag in 1 case / 500 mL in 1 bag | 63323-522-77 | Fresenius Kabi | 24 August 2017 |
| 30 pouch in 1 case / 1 bag in 1 pouch / 250 mL in 1 bag | 0409-0012-30 | Hospira | 27 February 2023 |
| 20 pouch in 1 case / 1 bag in 1 pouch / 500 mL in 1 bag | 0409-3150-20 | Hospira | 3 January 2023 |
| 24 container in 1 case / 500 mL in 1 container | 0264-3301-10 | B. Braun Medical | 18 July 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 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/100 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.