Medicine
Orphenadrine 60 mg/2 mL injection
Orphenadrine 60 mg/2 mL injection is a generic prescription medicine for intramuscular, 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
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Orphenadrine
- Brand
- Sold under the generic name
- Strength
- 60 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 ampules of 2 mL, 25 boxes of 2 mL, 10 vials of 2 mL
- Manufacturers
- Actavis PharmaHikma PharmaceuticalsSagent Pharmaceuticals
- 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). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M03BC01 Orphenadrine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 April 2003
- Identifiers
- RxCUI 994541DailyMed set ID c8d8596a-b81f-4b83-a2f3-a55922ca4a82, aec8ad3a-f717-4e74-b7b9-19debdaad79a, ed406e8a-ec00-4711-ae2b-3c5af4f15438NDC 25021-651, 0591-3222, 0641-6182Application ANDA090585, ANDA084779, ANDA040463
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 |
|---|---|---|---|
| 10 ampule in 1 carton / 2 mL in 1 ampule | 0591-3222-47 | Actavis Pharma | 8 July 2010 |
| 25 box in 1 box / 10 vial in 1 box / 2 mL in 1 vial | 0641-6182-25 | Hikma Pharmaceuticals | 28 April 2003 |
| 10 vial in 1 carton / 2 mL in 1 vial | 25021-651-02 | Sagent Pharmaceuticals | 1 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 10 May 1957 | 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 Orphenadrine
Clinical summary
Orphenadrine is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. MedsAcross supplies Orphenadrine 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 OrphenadrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ORPHENADRINE CITRATE prescribing information (Lupin) · U.S. National Library of Medicine, DailyMed
Need Orphenadrine 60 mg/2 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.