Medicine
Cyclobenzaprine 15 mg extended-release capsule
Cyclobenzaprine 15 mg extended-release capsule 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Cyclobenzaprine
- Brand
- Sold under the generic name
- Strength
- 15 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 60 capsules, 10 blister pack, 30 capsules and 48 more
- Manufacturers
- Macleods PharmaceuticalsIndiaProficient RxAdvanced Rx of TennesseeBryant Ranch PrepackPhoenix RXPreferred PharmaceuticalsDirect_RxAmneal Pharmaceuticals of New YorkDoc RxTeva Pharmaceuticals14 labelers on the register
- 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 828358, 828353DailyMed set ID 550d3e5a-c95f-4094-a500-1a02ea35a18d, ba659e1a-0091-45f6-b418-f4f36c9a2c79, 3dd2bde1-f06d-493a-91c7-22b28a5e1699 +19NDC 68788-8522, 70518-4225, 76420-895 +19Application 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
A sample of 40 packs from 14 labelers. The register lists 51 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 capsule, extended release in 1 bottle | 33342-272-09 | Macleods PharmaceuticalsIndia | 22 July 2024 |
| 10 blister pack in 1 carton / 10 capsule, extended release in 1 blister pack | 33342-272-12 | Macleods PharmaceuticalsIndia | 22 July 2024 |
| 60 capsule, extended release in 1 bottle | 0115-1436-13 | Amneal Pharmaceuticals of New York | 1 March 2019 |
| 30 capsule, extended release in 1 bottle | 69306-015-03 | Doc Rx | 4 September 2025 |
| 60 capsule, extended release in 1 bottle | 0093-1920-06 | Teva Pharmaceuticals | 4 March 2019 |
| 60 capsule, extended release in 1 bottle | 24979-035-04 | Upsher-Smith Laboratories | 1 March 2019 |
| 60 capsule, extended release in 1 bottle | 72189-101-60 | Direct RX | 7 May 2020 |
| 60 capsule, extended release in 1 bottle | 72189-362-60 | Direct_Rx | 25 July 2022 |
| 60 capsule, extended release in 1 bottle | 72189-389-60 | Direct_Rx | 9 November 2022 |
| 30 capsule, extended release in 1 bottle | 80425-0451-1 | Advanced Rx of Tennessee | 29 October 2024 |
| 60 capsule, extended release in 1 bottle | 80425-0451-2 | Advanced Rx of Tennessee | 29 October 2024 |
| 90 capsule, extended release in 1 bottle | 80425-0451-3 | Advanced Rx of Tennessee | 29 October 2024 |
| 30 capsule, extended release in 1 bottle | 80425-0460-1 | Advanced Rx of Tennessee | 18 December 2024 |
| 60 capsule, extended release in 1 bottle | 80425-0460-2 | Advanced Rx of Tennessee | 18 December 2024 |
| 90 capsule, extended release in 1 bottle | 80425-0460-3 | Advanced Rx of Tennessee | 18 December 2024 |
| 30 capsule, extended release in 1 bottle | 63629-8206-1 | Bryant Ranch Prepack | 8 July 2024 |
| 90 capsule, extended release in 1 bottle | 63629-8206-2 | Bryant Ranch Prepack | 8 July 2024 |
| 60 capsule, extended release in 1 bottle | 63629-8206-3 | Bryant Ranch Prepack | 8 July 2024 |
| 30 capsule, extended release in 1 bottle | 71335-2514-1 | Bryant Ranch Prepack | 24 October 2024 |
| 90 capsule, extended release in 1 bottle | 71335-2514-2 | Bryant Ranch Prepack | 24 October 2024 |
| 60 capsule, extended release in 1 bottle | 71335-2514-3 | Bryant Ranch Prepack | 24 October 2024 |
| 30 capsule, extended release in 1 bottle | 85509-1035-3 | Phoenix RX | 19 January 2026 |
| 60 capsule, extended release in 1 bottle | 85509-1035-6 | Phoenix RX | 19 January 2026 |
| 90 capsule, extended release in 1 bottle | 85509-1035-9 | Phoenix RX | 19 January 2026 |
| 30 capsule, extended release in 1 bottle | 85509-1920-3 | Phoenix RX | 21 July 2025 |
| 60 capsule, extended release in 1 bottle | 85509-1920-6 | Phoenix RX | 21 July 2025 |
| 90 capsule, extended release in 1 bottle | 85509-1920-9 | Phoenix RX | 21 July 2025 |
| 30 capsule, extended release in 1 bottle | 68788-4087-3 | Preferred Pharmaceuticals | 17 March 2026 |
| 60 capsule, extended release in 1 bottle | 68788-4087-6 | Preferred Pharmaceuticals | 17 March 2026 |
| 30 capsule, extended release in 1 bottle | 68788-8522-3 | Preferred Pharmaceuticals | 12 September 2023 |
| 60 capsule, extended release in 1 bottle | 68788-8522-6 | Preferred Pharmaceuticals | 28 September 2023 |
| 30 capsule, extended release in 1 bottle | 71205-454-30 | Proficient Rx | 26 May 2020 |
| 42 capsule, extended release in 1 bottle | 71205-454-42 | Proficient Rx | 26 May 2020 |
| 60 capsule, extended release in 1 bottle | 71205-454-60 | Proficient Rx | 26 May 2020 |
| 90 capsule, extended release in 1 bottle | 71205-454-90 | Proficient Rx | 26 May 2020 |
| 100 capsule, extended release in 1 bottle | 71205-857-00 | Proficient Rx | 6 May 2022 |
| 1000 capsule, extended release in 1 bottle | 71205-857-11 | Proficient Rx | 6 May 2022 |
| 30 capsule, extended release in 1 bottle | 71205-857-30 | Proficient Rx | 6 May 2022 |
| 500 capsule, extended release in 1 bottle | 71205-857-55 | Proficient Rx | 6 May 2022 |
| 60 capsule, extended release in 1 bottle | 71205-857-60 | 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 15 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 15 mg extended-release capsule 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.