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MedsAcross

Medicine

Enoxaparin 300 mg/3 mL injection

Enoxaparin · Intravenous, subcutaneous
Available on requestPrescription onlyUS FDAGeneric name

Enoxaparin 300 mg/3 mL injection is a generic prescription medicine for intravenous, subcutaneous use, made by 4 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

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 25°C (77°F), excursions permitted to 15°C–30°C (59°F–86°F). Store in…

Key facts

Active ingredient (INN)
Enoxaparin
Brand
Sold under the generic name
Strength
300 mg/3 mL
Dosage form
Injection
Route
Intravenous, subcutaneous
Packs
1 vial of 3 mL and 3 more
Manufacturers
Fresenius KabiMeitheal PharmaceuticalsAmphastar PharmaceuticalsBluePoint Laboratories
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15°C–30°C (59°F–86°F). Store in the original carton or packaging until ready to use. Do not store the multiple-dose vials for more than 28 days after the first use.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
B01AB05 Enoxaparin
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
18 June 2019
Identifiers
RxCUI 854228, 854235, 854238 +5DailyMed set ID 21b095d1-5ade-43e9-9114-30fbfb2331c9, 066f27ec-352c-4051-ba29-248e292690db, 7d38c307-767f-4c38-ac0e-b8bb62782602 +3NDC 63323-539, 71288-426, 68001-641 +1Application NDA020164, ANDA214856, ANDA208600

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.

PackCodeLabelerMarketed since
1 vial, multi-dose in 1 carton / 3 mL in 1 vial, multi-dose63323-539-03Fresenius Kabi18 June 2019
1 vial, multi-dose in 1 carton / 3 mL in 1 vial, multi-dose63323-539-13Fresenius Kabi18 June 2019
1 vial, multi-dose in 1 carton / 3 mL in 1 vial, multi-dose71288-426-03Meitheal Pharmaceuticals14 June 2022
1 vial, multi-dose in 1 carton / 3 mL in 1 vial, multi-dose71288-426-91Meitheal Pharmaceuticals14 June 2022
1 vial in 1 carton / 3 mL in 1 vial0548-5608-00Amphastar Pharmaceuticals11 November 2019
1 vial, multi-dose in 1 carton / 3 mL in 1 vial, multi-dose68001-641-41BluePoint Laboratories1 May 2025
1 vial, multi-dose in 1 carton / 3 mL in 1 vial, multi-dose0955-1016-01—3 October 2011

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 29 March 1993Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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

Alternatives

Other makers and brands of Enoxaparin 300 mg/3 mL injection.

Compare all 2

Other strengths and forms of Enoxaparin

Clinical summary

Enoxaparin is a low molecular weight heparin indicated for prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness. MedsAcross supplies Enoxaparin 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 Enoxaparin

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

Data sources

Need Enoxaparin 300 mg/3 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.