Medicine
Duloxetine 40 mg delayed-release capsule
Duloxetine 40 mg delayed-release capsule is a generic prescription medicine for oral use, made by 11 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Key facts
- Active ingredient (INN)
- Duloxetine
- Brand
- Sold under the generic name
- Strength
- 40 mg
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 30 capsules, 500 capsules, 1000 capsules and 32 more
- Manufacturers
- Ajanta PharmaIndiaLupinIndiaAsclemedPreferred PharmaceuticalsBreckenridge PharmaceuticalHawaii RepackBryant Ranch PrepackProficient RxBluePoint LaboratoriesQuallent Pharmaceuticals Health
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AX21 Duloxetine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 December 2013
- Identifiers
- RxCUI 616402, 596926, 596930 +1DailyMed set ID a95cc04c-58e9-487f-8992-ef30df03a3cd, f66f63c8-51db-4183-a452-78205cf3a263, f61bd9f3-cd3d-4c76-a110-0f1dcba610af +13NDC 68001-368, 72162-1600, 76420-636 +14Application ANDA203088, ANDA208706, ANDA090694
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 |
|---|---|---|---|
| 30 capsule, delayed release in 1 bottle | 27241-164-30 | Ajanta PharmaIndia | 25 March 2019 |
| 30 capsule, delayed release in 1 bottle | 68180-297-06 | LupinIndia | 15 July 2015 |
| 500 capsule, delayed release pellets in 1 bottle | 51991-750-05 | Breckenridge Pharmaceutical | 21 May 2018 |
| 1000 capsule, delayed release pellets in 1 bottle | 51991-750-10 | Breckenridge Pharmaceutical | 21 May 2018 |
| 30 capsule, delayed release pellets in 1 bottle | 51991-750-33 | Breckenridge Pharmaceutical | 21 May 2018 |
| 90 capsule, delayed release pellets in 1 bottle | 51991-750-90 | Breckenridge Pharmaceutical | 21 May 2018 |
| 30 capsule, delayed release pellets in 1 bottle | 63629-2063-1 | Bryant Ranch Prepack | 21 May 2018 |
| 30 capsule, delayed release pellets in 1 bottle | 63629-9187-1 | Bryant Ranch Prepack | 3 August 2022 |
| 30 capsule, delayed release pellets in 1 bottle | 72162-1600-3 | Bryant Ranch Prepack | 21 May 2018 |
| 100 capsule, delayed release in 1 bottle | 76420-636-01 | Asclemed | 17 October 2023 |
| 20 capsule, delayed release in 1 bottle | 76420-636-20 | Asclemed | 3 April 2025 |
| 30 capsule, delayed release in 1 bottle | 76420-636-30 | Asclemed | 17 October 2023 |
| 90 capsule, delayed release in 1 bottle | 76420-636-90 | Asclemed | 17 October 2023 |
| 120 capsule, delayed release in 1 bottle | 87063-704-12 | Asclemed | 2 July 2026 |
| 30 capsule, delayed release in 1 bottle | 87063-704-30 | Asclemed | 2 July 2026 |
| 60 capsule, delayed release in 1 bottle | 87063-704-60 | Asclemed | 2 July 2026 |
| 90 capsule, delayed release in 1 bottle | 87063-704-90 | Asclemed | 2 July 2026 |
| 30 capsule, delayed release pellets in 1 bottle | 68001-368-04 | BluePoint Laboratories | 21 May 2018 |
| 30 capsule, delayed release in 1 bottle | 68001-570-04 | BluePoint Laboratories | 28 July 2023 |
| 60 capsule, delayed release pellets in 1 bottle | 68788-8362-0 | Preferred Pharmaceuticals | 14 March 2023 |
| 30 capsule, delayed release pellets in 1 bottle | 68788-8362-3 | Preferred Pharmaceuticals | 1 February 2023 |
| 90 capsule, delayed release pellets in 1 bottle | 68788-8362-9 | Preferred Pharmaceuticals | 1 February 2023 |
| 30 capsule, delayed release in 1 bottle | 68788-8782-3 | Preferred Pharmaceuticals | 11 December 2024 |
| 60 capsule, delayed release in 1 bottle | 68788-8782-6 | Preferred Pharmaceuticals | 11 December 2024 |
| 90 capsule, delayed release in 1 bottle | 68788-8782-9 | Preferred Pharmaceuticals | 11 December 2024 |
| 90 capsule, delayed release pellets in 1 bottle | 82009-031-90 | Quallent Pharmaceuticals Health | 1 June 2023 |
| 30 capsule, delayed release in 1 bottle | 82009-172-30 | Quallent Pharmaceuticals Health | 1 July 2025 |
| 30 capsule, delayed release in 1 bottle | 51407-809-30 | Golden State Medical Supply | 10 July 2026 |
| 30 capsule, delayed release in 1 bottle | 85534-0053-0 | Hawaii Repack | 2 July 2026 |
| 60 capsule, delayed release in 1 bottle | 85534-0053-1 | Hawaii Repack | 2 July 2026 |
| 90 capsule, delayed release in 1 bottle | 85534-0053-2 | Hawaii Repack | 2 July 2026 |
| 120 capsule, delayed release in 1 bottle | 85534-0053-3 | Hawaii Repack | 2 July 2026 |
| 30 capsule, delayed release pellets in 1 bottle | 82804-024-30 | Proficient Rx | 16 October 2023 |
| 60 capsule, delayed release pellets in 1 bottle | 82804-024-60 | Proficient Rx | 16 October 2023 |
| 90 capsule, delayed release pellets in 1 bottle | 82804-024-90 | Proficient Rx | 16 October 2023 |
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.
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 Duloxetine 40 mg delayed-release capsule.
Other strengths and forms of Duloxetine
Clinical summary
Duloxetine is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major Depressive Disorder in adults, among other approved uses. It is available as delayed-release capsules for oral use. MedsAcross supplies Duloxetine 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 DuloxetineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DRIZALMA SPRINKLE prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
- Cymbalta: European public assessment report (EPAR) · European Medicines Agency
- Duloxetine Lilly: European public assessment report (EPAR) · European Medicines Agency
Need Duloxetine 40 mg delayed-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.