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MedsAcross

Medicine

Fragmin 10000 IU/mL injection

Dalteparin · Subcutaneous · Pfizer Laboratories
Available on requestPrescription onlyUS FDA

Fragmin 10000 IU/mL injection is a prescription medicine containing Dalteparin for subcutaneous use, marketed by Pfizer Laboratories, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20°C to 25°C (68°F to 77°F), excursion permitted between 15°C to 30°C…

Key facts

Active ingredient (INN)
Dalteparin
Brand
Fragmin
Strength
10000 IU/mL
Dosage form
Injection
Route
Subcutaneous
Packs
10 syringes
Marketing authorisation holder
Pfizer Laboratories
Manufacturer
Pfizer Laboratories
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursion permitted between 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
B01AB04 Dalteparin
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 April 2015
Identifiers
RxCUI 978725, 978727, 978733 +7DailyMed set ID 23527b8b-9b28-4e6d-9751-33b143975ac7NDC 0069-0217Application NDA020287

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

PackCodeLabelerMarketed since
10 syringe in 1 carton / 1 mL in 1 syringe0069-0217-02Pfizer Laboratories1 April 2015

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 22 December 1994Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Dalteparin

Clinical summary

Dalteparin is an anti-coagulant indicated for prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Dalteparin 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 Dalteparin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Fragmin 10000 IU/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.