Medicine
Cyclobenzaprine 5 mg tablet
Cyclobenzaprine 5 mg tablet is a generic prescription medicine for oral use, made by 39 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)
- Cyclobenzaprine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 252 more
- Manufacturers
- Unichem LaboratoriesIndiaAlembic PharmaceuticalsIndiaAurobindo PharmaIndiaCiplaIndiaJubilant Cadista PharmaceuticalsIndiaRising Pharma HoldingsSolco HealthcareAdvagen PharmaAiPing PharmaceuticalAmneal Pharmaceuticals39 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
- M03BX08 Cyclobenzaprine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 April 2006
- Identifiers
- RxCUI 828320, 828299, 828348DailyMed set ID 59b428fa-5013-4b2b-872f-16ba4a9d4f5d, 820dca15-5b7f-41e0-955f-73f942709264, 1d9e34cc-eee9-4147-abf8-c810a80e39d2 +37NDC 72789-115, 76420-839, 0093-3420 +37Application ANDA077797, ANDA213324, ANDA071611 +8
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 39 labelers. The register lists 255 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 62332-646-31 | Alembic PharmaceuticalsIndia | 18 February 2010 |
| 500 tablet, film coated in 1 bottle | 62332-646-71 | Alembic PharmaceuticalsIndia | 18 February 2010 |
| 1000 tablet, film coated in 1 bottle | 62332-646-91 | Alembic PharmaceuticalsIndia | 18 February 2010 |
| 100 tablet, film coated in 1 bottle | 65862-190-01 | Aurobindo PharmaIndia | 26 September 2008 |
| 500 tablet, film coated in 1 bottle | 65862-190-05 | Aurobindo PharmaIndia | 26 September 2008 |
| 1000 tablet, film coated in 1 bottle | 65862-190-99 | Aurobindo PharmaIndia | 26 September 2008 |
| 100 tablet, film coated in 1 bottle | 69097-845-07 | CiplaIndia | 22 July 2016 |
| 1000 tablet, film coated in 1 bottle | 69097-845-15 | CiplaIndia | 22 July 2016 |
| 100 tablet, film coated in 1 bottle | 59746-211-06 | Jubilant Cadista PharmaceuticalsIndia | 4 April 2006 |
| 1000 tablet, film coated in 1 bottle | 59746-211-10 | Jubilant Cadista PharmaceuticalsIndia | 4 April 2006 |
| 100 tablet, film coated in 1 bottle | 29300-413-01 | Unichem LaboratoriesIndia | 30 September 2020 |
| 500 tablet, film coated in 1 bottle | 29300-413-05 | Unichem LaboratoriesIndia | 30 September 2020 |
| 1000 tablet, film coated in 1 bottle | 29300-413-10 | Unichem LaboratoriesIndia | 30 September 2020 |
| 90 tablet, film coated in 1 bottle | 29300-413-19 | Unichem LaboratoriesIndia | 18 November 2021 |
| 100 tablet, film coated in 1 bottle | 16571-782-01 | Rising Pharma Holdings | 26 September 2008 |
| 1000 tablet, film coated in 1 bottle | 16571-782-10 | Rising Pharma Holdings | 26 September 2008 |
| 500 tablet, film coated in 1 bottle | 16571-782-50 | Rising Pharma Holdings | 26 September 2008 |
| 100 tablet in 1 bottle | 64980-655-01 | Rising Pharma Holdings | 19 February 2025 |
| 1000 tablet in 1 bottle | 64980-655-10 | Rising Pharma Holdings | 19 February 2025 |
| 500 tablet in 1 bottle | 64980-655-50 | Rising Pharma Holdings | 19 February 2025 |
| 1000 tablet, film coated in 1 bottle | 72888-012-00 | Advagen Pharma | 1 November 2021 |
| 100 tablet, film coated in 1 bottle | 72888-012-01 | Advagen Pharma | 31 May 2017 |
| 500 tablet, film coated in 1 bottle | 72888-012-05 | Advagen Pharma | 31 May 2017 |
| 100 tablet, film coated in 1 bottle | 11788-093-01 | AiPing Pharmaceutical | 23 October 2026 |
| 500 tablet, film coated in 1 bottle | 11788-093-05 | AiPing Pharmaceutical | 23 October 2026 |
| 1000 tablet, film coated in 1 bottle | 11788-093-10 | AiPing Pharmaceutical | 23 October 2026 |
| 100 tablet, film coated in 1 bottle | 65162-540-10 | Amneal Pharmaceuticals | 18 February 2010 |
| 1000 tablet, film coated in 1 bottle | 65162-540-11 | Amneal Pharmaceuticals | 18 February 2010 |
| 500 tablet, film coated in 1 bottle | 65162-540-50 | Amneal Pharmaceuticals | 18 February 2010 |
| 100 tablet, film coated in 1 bottle | 53746-540-01 | Amneal Pharmaceuticals of New York | 18 February 2010 |
| 500 tablet, film coated in 1 bottle | 53746-540-05 | Amneal Pharmaceuticals of New York | 18 February 2010 |
| 1000 tablet, film coated in 1 bottle | 53746-540-10 | Amneal Pharmaceuticals of New York | 18 February 2010 |
| 100 tablet, film coated in 1 bottle | 10702-006-01 | Kvk-Tech | 31 July 2014 |
| 1000 tablet, film coated in 1 bottle | 10702-006-10 | Kvk-Tech | 31 July 2014 |
| 500 tablet, film coated in 1 bottle | 10702-006-50 | Kvk-Tech | 31 July 2014 |
| 90 tablet, film coated in 1 bottle | 82461-714-90 | Medcore | 11 January 2026 |
| 10 tablet, film coated in 1 bottle, plastic | 43547-399-01 | Solco Healthcare | 30 March 2017 |
| 100 tablet, film coated in 1 bottle, plastic | 43547-399-10 | Solco Healthcare | 30 March 2017 |
| 1000 tablet, film coated in 1 bottle, plastic | 43547-399-11 | Solco Healthcare | 30 March 2017 |
| 500 tablet, film coated in 1 bottle, plastic | 43547-399-50 | Solco Healthcare | 30 March 2017 |
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 26 August 1977 | 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 Cyclobenzaprine
Clinical summary
Cyclobenzaprine is a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. MedsAcross supplies Cyclobenzaprine 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 CyclobenzaprineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cyclobenzaprine Hydrochloride prescribing information (Amneal Pharmaceuticals of New York) · U.S. National Library of Medicine, DailyMed
Need Cyclobenzaprine 5 mg tablet for your hospital or patient?
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