Medicine
Dexlansoprazole 60 mg delayed-release capsule
Dexlansoprazole 60 mg delayed-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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Dexlansoprazole
- Brand
- Sold under the generic name
- Strength
- 60 mg
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 30 capsules, 90 capsules and 19 more
- Manufacturers
- Alembic PharmaceuticalsIndiaA-S Medication SolutionsBryant Ranch PrepackGolden State Medical SupplyMylan PharmaceuticalsPar HealthUpsher-Smith LaboratoriesRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A02BC06 Dexlansoprazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 January 2022
- Identifiers
- RxCUI 833204, 833213DailyMed set ID 24c33ba6-bf47-434e-903e-f7ced98e030e, d7452a26-db20-42fc-868a-a3e3606ca895, 7c7698da-3cda-4301-ae93-02fb64b9c90d +9NDC 46708-824, 49884-148, 50090-5944 +9Application ANDA219115, ANDA202294, NDA022287 +2
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 | 46708-824-30 | Alembic PharmaceuticalsIndia | 14 November 2025 |
| 90 capsule, delayed release in 1 bottle | 46708-824-90 | Alembic PharmaceuticalsIndia | 14 November 2025 |
| 30 capsule, delayed release in 1 bottle | 62332-824-30 | Alembic PharmaceuticalsIndia | 14 November 2025 |
| 90 capsule, delayed release in 1 bottle | 62332-824-90 | Alembic PharmaceuticalsIndia | 14 November 2025 |
| 90 capsule, delayed release pellets in 1 bottle, plastic | 0378-2086-77 | Mylan Pharmaceuticals | 22 January 2024 |
| 30 capsule, delayed release pellets in 1 bottle, plastic | 0378-2086-93 | Mylan Pharmaceuticals | 22 January 2024 |
| 90 capsule, delayed release in 1 bottle | 49884-148-09 | Par Health | 22 November 2022 |
| 30 capsule, delayed release in 1 bottle | 49884-148-11 | Par Health | 22 November 2022 |
| 30 capsule, delayed release in 1 bottle | 24979-002-06 | Upsher-Smith Laboratories | 1 December 2022 |
| 90 capsule, delayed release in 1 bottle | 24979-002-07 | Upsher-Smith Laboratories | 1 December 2022 |
| 30 capsule, delayed release in 1 bottle | 50090-5944-0 | A-S Medication Solutions | 17 March 2022 |
| 90 capsule, delayed release in 1 bottle | 50090-5944-1 | A-S Medication Solutions | 1 April 2022 |
| 30 capsule, delayed release in 1 bottle | 50090-6514-0 | A-S Medication Solutions | 1 June 2023 |
| 90 capsule, delayed release in 1 bottle | 50090-6514-1 | A-S Medication Solutions | 1 June 2023 |
| 30 capsule, delayed release in 1 bottle | 50090-7451-0 | A-S Medication Solutions | 11 November 2024 |
| 90 capsule, delayed release in 1 bottle | 50090-7451-1 | A-S Medication Solutions | 11 November 2024 |
| 30 capsule, delayed release in 1 bottle | 72162-2214-3 | Bryant Ranch Prepack | 5 January 2024 |
| 30 capsule, delayed release in 1 bottle | 72162-2239-3 | Bryant Ranch Prepack | 1 December 2022 |
| 90 capsule, delayed release in 1 bottle | 72162-2239-9 | Bryant Ranch Prepack | 1 December 2022 |
| 30 capsule, delayed release in 1 bottle | 51407-747-30 | Golden State Medical Supply | 11 January 2023 |
| 90 capsule, delayed release in 1 bottle | 51407-747-90 | Golden State Medical Supply | 11 January 2023 |
| 30 capsule, delayed release in 1 bottle, plastic | 70518-4791-0 | Remedyrepack | 4 November 2026 |
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 30 January 2009 | 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 Dexlansoprazole 60 mg delayed-release capsule.
Other strengths and forms of Dexlansoprazole
Clinical summary
Dexlansoprazole is a proton pump inhibitor indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE), among other approved uses. It is available as delayed-release capsules for oral use. MedsAcross supplies Dexlansoprazole 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 DexlansoprazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dexilant prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Dexlansoprazole 60 mg delayed-release capsule for your hospital or patient?
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