Medicine
Cyclobenzaprine 30 mg extended-release capsule
Cyclobenzaprine 30 mg extended-release capsule is a generic prescription medicine for oral use, made by 8 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).
Key facts
- Active ingredient (INN)
- Cyclobenzaprine
- Brand
- Sold under the generic name
- Strength
- 30 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 60 capsules, 10 blister pack, 30 capsules and 17 more
- Manufacturers
- Macleods PharmaceuticalsIndiaProficient RxAsclemedBryant Ranch PrepackRemedyrepackAmneal Pharmaceuticals of New YorkTeva PharmaceuticalsUpsher-Smith Laboratories
- 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
- M03BX08 Cyclobenzaprine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 March 2019
- Identifiers
- RxCUI 828353, 828358DailyMed set ID 3dd2bde1-f06d-493a-91c7-22b28a5e1699, 3175d24d-e8a0-4f14-bed9-a60ad59ac7e7, dd546a0e-e5be-4232-8ad8-fcd7d5f9a903 +6NDC 76420-896, 70518-4174, 0115-1437 +6Application ANDA091281, NDA021777, ANDA207314
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 |
|---|---|---|---|
| 60 capsule, extended release in 1 bottle | 33342-273-09 | Macleods PharmaceuticalsIndia | 22 July 2024 |
| 10 blister pack in 1 carton / 10 capsule, extended release in 1 blister pack | 33342-273-12 | Macleods PharmaceuticalsIndia | 22 July 2024 |
| 60 capsule, extended release in 1 bottle | 0115-1437-13 | Amneal Pharmaceuticals of New York | 1 March 2019 |
| 60 capsule, extended release in 1 bottle | 0093-1921-06 | Teva Pharmaceuticals | 4 March 2019 |
| 60 capsule, extended release in 1 bottle | 24979-036-04 | Upsher-Smith Laboratories | 1 March 2019 |
| 30 capsule, extended release in 1 bottle, plastic | 70518-4174-0 | Remedyrepack | 4 September 2024 |
| 30 capsule, extended release in 1 bottle, plastic | 70518-4523-0 | Remedyrepack | 25 November 2025 |
| 100 capsule, extended release in 1 bottle | 76420-896-01 | Asclemed | 7 January 2025 |
| 30 capsule, extended release in 1 bottle | 76420-896-30 | Asclemed | 7 January 2025 |
| 60 capsule, extended release in 1 bottle | 76420-896-60 | Asclemed | 7 January 2025 |
| 90 capsule, extended release in 1 bottle | 76420-896-90 | Asclemed | 7 January 2025 |
| 30 capsule, extended release in 1 bottle | 71335-2696-1 | Bryant Ranch Prepack | 24 September 2025 |
| 60 capsule, extended release in 1 bottle | 71335-2696-2 | Bryant Ranch Prepack | 24 September 2025 |
| 100 capsule, extended release in 1 bottle | 71205-858-00 | Proficient Rx | 6 May 2022 |
| 1000 capsule, extended release in 1 bottle | 71205-858-11 | Proficient Rx | 6 May 2022 |
| 30 capsule, extended release in 1 bottle | 71205-858-30 | Proficient Rx | 6 May 2022 |
| 500 capsule, extended release in 1 bottle | 71205-858-55 | Proficient Rx | 6 May 2022 |
| 60 capsule, extended release in 1 bottle | 71205-858-60 | Proficient Rx | 6 May 2022 |
| 120 capsule, extended release in 1 bottle | 71205-858-72 | Proficient Rx | 6 May 2022 |
| 90 capsule, extended release in 1 bottle | 71205-858-90 | Proficient Rx | 6 May 2022 |
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
Alternatives
Other makers and brands of Cyclobenzaprine 30 mg extended-release capsule.
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 30 mg extended-release capsule for your hospital or patient?
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