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Medicine

Procainamide 1000 mg/10 mL injection

Procainamide · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAGeneric name

Procainamide 1000 mg/10 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 10 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 20˚ to 25˚C (68˚ to 77˚F).

Key facts

Active ingredient (INN)
Procainamide
Brand
Sold under the generic name
Strength
1000 mg/10 mL
Dosage form
Injection
Route
Intramuscular, intravenous
Packs
10 vials of 10 mL, 25 cartons of 10 mL, 5 syringes of 10 mL and 10 more
Manufacturers
Caplin SterilesIndiaGland PharmaIndiaHealthFirstMedical Purchasing SolutionsHospiraInternational Medication SystemsNexus PharmaceuticalsProPharma DistributionRemedyrepackSagent Pharmaceuticals
Origin register
US FDA, United States
Storage
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
C01BA02 Procainamide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
8 March 2006
Identifiers
RxCUI 1862220, 857886, 857962DailyMed set ID 3d5d9d6e-1f1c-7565-e063-6394a90a93e7, fece65c0-fdbc-61d8-e053-6294a90a9a68, 8192d79d-da2b-2532-e053-2991aa0ae8ad +9NDC 84549-399, 51662-1630, 51662-1334 +9Application ANDA088636, ANDA089069, ANDA218135 +2

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
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose65145-155-10Caplin SterilesIndia17 February 2025
25 carton in 1 case / 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose68083-603-25Gland PharmaIndia22 July 2024
25 carton in 1 case / 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose0409-1902-01Hospira8 March 2006
5 syringe in 1 package / 10 mL in 1 syringe76329-3399-5International Medication Systems21 December 2016
10 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose14789-901-10Nexus Pharmaceuticals14 October 2007
10 vial in 1 carton / 10 mL in 1 vial25021-322-10Sagent Pharmaceuticals15 January 2025
1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose51662-1334-1HealthFirst10 February 2019
25 pouch in 1 box / 1 vial, multi-dose in 1 pouch / 10 mL in 1 vial, multi-dose51662-1334-3HealthFirst15 March 2022
5 pouch in 1 case / 1 box in 1 pouch / 1 syringe in 1 box / 10 mL in 1 syringe51662-1630-3HealthFirst23 June 2023
1 carton in 1 bag / 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose71872-7113-1Medical Purchasing Solutions12 September 2023
1 vial in 1 bag / 10 mL in 1 vial71872-7353-1Medical Purchasing Solutions28 May 2025
10 mL in 1 syringe84549-399-05ProPharma Distribution1 September 2025
5 syringe in 1 package / 10 mL in 1 syringe70518-4208-0Remedyrepack10 October 2024

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 2 June 1950Drugs@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 Procainamide

Clinical summary

Procainamide is an antiarrhythmic indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. It is available as injection for intramuscular and intravenous use. MedsAcross supplies Procainamide 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 Procainamide

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

Data sources

Need Procainamide 1000 mg/10 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.