Medicine
Orphenadrine 100 mg extended-release tablet
Orphenadrine 100 mg extended-release tablet is a generic prescription medicine for oral use, made by 14 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°-25°C (68°-77°F).
Key facts
- Active ingredient (INN)
- Orphenadrine
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 49 more
- Manufacturers
- LupinIndiaBryant Ranch PrepackProficient RxAdvanced Rx Pharmacy of TennesseePD-Rx PharmaceuticalsA-S Medication SolutionsNuCare Pharmaceuticals,IncPreferred PharmaceuticalsNorthwind HealthSandoz14 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F).
- 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
- 19 June 1998
- Identifiers
- RxCUI 994521DailyMed set ID 1b4e379e-8051-421f-a0f4-ad9e6fb9476a, 239018ff-cec6-46de-ae9d-26c9ec034a32, 7905e80f-b60b-48e8-8e63-a3e50211bfe4 +14NDC 72162-2020, 0185-0022, 70518-4506 +14Application ANDA040284, ANDA040327
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
A sample of 40 packs from 14 labelers. The register lists 52 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle | 43386-480-24 | LupinIndia | 19 June 1998 |
| 500 tablet, extended release in 1 bottle | 43386-480-26 | LupinIndia | 19 June 1998 |
| 1000 tablet, extended release in 1 bottle | 43386-480-28 | LupinIndia | 19 June 1998 |
| 100 tablet, extended release in 1 bottle | 0185-0022-01 | Sandoz | 15 February 2000 |
| 30 tablet, extended release in 1 bottle | 80425-0117-1 | Advanced Rx Pharmacy of Tennessee | 19 June 1998 |
| 60 tablet, extended release in 1 bottle | 80425-0117-2 | Advanced Rx Pharmacy of Tennessee | 17 August 2023 |
| 30 tablet, extended release in 1 bottle | 80425-0340-1 | Advanced Rx Pharmacy of Tennessee | 23 May 2023 |
| 60 tablet, extended release in 1 bottle | 80425-0340-2 | Advanced Rx Pharmacy of Tennessee | 17 August 2023 |
| 56 tablet, extended release in 1 bottle | 63629-1564-0 | Bryant Ranch Prepack | 22 September 2006 |
| 20 tablet, extended release in 1 bottle | 63629-1564-1 | Bryant Ranch Prepack | 22 September 2006 |
| 60 tablet, extended release in 1 bottle | 63629-1564-2 | Bryant Ranch Prepack | 22 September 2006 |
| 100 tablet, extended release in 1 bottle | 63629-1564-3 | Bryant Ranch Prepack | 22 September 2006 |
| 90 tablet, extended release in 1 bottle | 63629-1564-4 | Bryant Ranch Prepack | 22 September 2006 |
| 30 tablet, extended release in 1 bottle | 63629-1564-5 | Bryant Ranch Prepack | 22 September 2006 |
| 28 tablet, extended release in 1 bottle | 63629-1564-6 | Bryant Ranch Prepack | 22 September 2006 |
| 45 tablet, extended release in 1 bottle | 63629-1564-7 | Bryant Ranch Prepack | 22 September 2006 |
| 14 tablet, extended release in 1 bottle | 63629-1564-8 | Bryant Ranch Prepack | 22 September 2006 |
| 120 tablet, extended release in 1 bottle | 63629-1564-9 | Bryant Ranch Prepack | 22 September 2006 |
| 100 tablet, extended release in 1 bottle | 72162-2020-1 | Bryant Ranch Prepack | 26 May 2023 |
| 500 tablet, extended release in 1 bottle | 72162-2020-5 | Bryant Ranch Prepack | 26 May 2023 |
| 60 tablet, extended release in 1 bottle | 72162-2020-6 | Bryant Ranch Prepack | 26 May 2023 |
| 20 tablet, extended release in 1 bottle | 63187-122-20 | Proficient Rx | 2 February 2015 |
| 30 tablet, extended release in 1 bottle | 63187-122-30 | Proficient Rx | 2 February 2015 |
| 60 tablet, extended release in 1 bottle | 63187-122-60 | Proficient Rx | 2 February 2015 |
| 90 tablet, extended release in 1 bottle | 63187-122-90 | Proficient Rx | 2 February 2015 |
| 30 tablet, extended release in 1 bottle | 63187-632-30 | Proficient Rx | 1 January 2016 |
| 60 tablet, extended release in 1 bottle | 63187-632-60 | Proficient Rx | 1 January 2016 |
| 90 tablet, extended release in 1 bottle | 63187-632-90 | Proficient Rx | 1 January 2016 |
| 20 tablet, extended release in 1 bottle | 50090-0169-0 | A-S Medication Solutions | 21 June 2016 |
| 30 tablet, extended release in 1 bottle | 50090-0169-1 | A-S Medication Solutions | 28 November 2014 |
| 60 tablet, extended release in 1 bottle | 50090-0169-5 | A-S Medication Solutions | 28 November 2014 |
| 14 tablet, extended release in 1 bottle, plastic | 82868-040-14 | Northwind Health | 30 January 2024 |
| 20 tablet, extended release in 1 bottle | 66267-158-20 | NuCare Pharmaceuticals | 12 October 2016 |
| 30 tablet, extended release in 1 bottle | 66267-158-30 | NuCare Pharmaceuticals | 12 October 2016 |
| 14 tablet, extended release in 1 bottle, plastic | 43063-407-14 | PD-Rx Pharmaceuticals | 18 June 2013 |
| 20 tablet, extended release in 1 bottle, plastic | 43063-407-20 | PD-Rx Pharmaceuticals | 18 June 2013 |
| 30 tablet, extended release in 1 bottle, plastic | 43063-407-30 | PD-Rx Pharmaceuticals | 18 June 2013 |
| 60 tablet, extended release in 1 bottle, plastic | 43063-407-60 | PD-Rx Pharmaceuticals | 18 June 2013 |
| 100 tablet, extended release in 1 bottle | 68788-9138-1 | Preferred Pharmaceuticals | 22 November 2011 |
| 20 tablet, extended release in 1 bottle | 68788-9138-2 | Preferred Pharmaceuticals | 22 November 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 100 mg extended-release tablet 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.