Medicine
Loperamide 2 mg capsule
Loperamide 2 mg capsule is a generic prescription medicine for oral use, made by 27 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)
- Loperamide
- Brand
- Sold under the generic name
- Strength
- 2 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 10 blister pack and 130 more
- Manufacturers
- Viona PharmaceuticalsIndiaZydus LifesciencesIndiaAurobindo PharmaIndiaBryant Ranch PrepackAdvagen Pharmaallphamed Pharbil ArzneimittelEdenbridge PharmaceuticalsBionpharmaMylan PharmaceuticalsTeva Pharmaceuticals27 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
- A07DA03 Loperamide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 September 1991
- Identifiers
- RxCUI 978006DailyMed set ID af0b886f-c065-26dc-e053-2995a90ac471, 1adb7a28-9dc6-3f8b-e063-6394a90a9335, 72a7ae47-cdf3-4949-b9f8-f29b153f787f +37NDC 68071-2257, 68071-3618, 0378-2100 +37Application ANDA073192, ANDA218122, ANDA072741 +4
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 27 labelers. The register lists 133 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 59651-691-01 | Aurobindo PharmaIndia | 5 September 2023 |
| 500 capsule in 1 bottle | 59651-691-05 | Aurobindo PharmaIndia | 5 September 2023 |
| 100 capsule in 1 bottle | 72578-138-01 | Viona PharmaceuticalsIndia | 25 June 2023 |
| 500 capsule in 1 bottle | 72578-138-05 | Viona PharmaceuticalsIndia | 25 June 2023 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 72578-138-77 | Viona PharmaceuticalsIndia | 25 June 2023 |
| 100 capsule in 1 bottle | 70771-1769-1 | Zydus LifesciencesIndia | 25 June 2023 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 70771-1769-4 | Zydus LifesciencesIndia | 25 June 2023 |
| 500 capsule in 1 bottle | 70771-1769-5 | Zydus LifesciencesIndia | 25 June 2023 |
| 1000 capsule in 1 bottle | 72888-130-00 | Advagen Pharma | 26 January 2023 |
| 100 capsule in 1 bottle | 72888-130-01 | Advagen Pharma | 26 January 2023 |
| 500 capsule in 1 bottle | 72888-130-05 | Advagen Pharma | 26 January 2023 |
| 30 capsule in 1 bottle | 72888-130-30 | Advagen Pharma | 26 January 2023 |
| 100 capsule in 1 bottle | 60468-005-01 | allphamed Pharbil Arzneimittel | 25 September 2020 |
| 500 capsule in 1 bottle | 60468-005-05 | allphamed Pharbil Arzneimittel | 25 September 2020 |
| 30 capsule in 1 bottle | 60468-005-30 | allphamed Pharbil Arzneimittel | 25 September 2020 |
| 100 capsule in 1 bottle, plastic | 69452-271-20 | Bionpharma | 1 December 2021 |
| 500 capsule in 1 bottle, plastic | 69452-271-30 | Bionpharma | 23 June 2022 |
| 100 capsule in 1 bottle | 42799-605-01 | Edenbridge Pharmaceuticals | 25 September 2020 |
| 500 capsule in 1 bottle | 42799-605-02 | Edenbridge Pharmaceuticals | 25 September 2020 |
| 30 capsule in 1 bottle | 42799-605-03 | Edenbridge Pharmaceuticals | 25 September 2020 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 51079-690-20 | Mylan Institutional | 10 March 1997 |
| 100 capsule in 1 bottle, plastic | 0378-2100-01 | Mylan Pharmaceuticals | 18 September 1991 |
| 500 capsule in 1 bottle, plastic | 0378-2100-05 | Mylan Pharmaceuticals | 18 September 1991 |
| 100 capsule in 1 bottle | 0093-0311-01 | Teva Pharmaceuticals | 1 May 1993 |
| 500 capsule in 1 bottle | 0093-0311-05 | Teva Pharmaceuticals | 1 May 1993 |
| 100 capsule in 1 bottle | 63629-8747-1 | Bryant Ranch Prepack | 20 August 2021 |
| 50 capsule in 1 bottle, plastic | 71335-1921-0 | Bryant Ranch Prepack | 3 May 2022 |
| 15 capsule in 1 bottle, plastic | 71335-1921-1 | Bryant Ranch Prepack | 30 July 2021 |
| 30 capsule in 1 bottle, plastic | 71335-1921-2 | Bryant Ranch Prepack | 30 August 2021 |
| 20 capsule in 1 bottle, plastic | 71335-1921-3 | Bryant Ranch Prepack | 18 August 2021 |
| 12 capsule in 1 bottle, plastic | 71335-1921-4 | Bryant Ranch Prepack | 20 August 2021 |
| 60 capsule in 1 bottle, plastic | 71335-1921-5 | Bryant Ranch Prepack | 3 May 2022 |
| 24 capsule in 1 bottle, plastic | 71335-1921-6 | Bryant Ranch Prepack | 30 July 2021 |
| 14 capsule in 1 bottle, plastic | 71335-1921-7 | Bryant Ranch Prepack | 3 May 2022 |
| 9 capsule in 1 bottle, plastic | 71335-1921-8 | Bryant Ranch Prepack | 26 July 2021 |
| 5 capsule in 1 bottle, plastic | 71335-1921-9 | Bryant Ranch Prepack | 23 February 2022 |
| 50 capsule in 1 bottle, plastic | 71335-2061-0 | Bryant Ranch Prepack | 3 April 2024 |
| 15 capsule in 1 bottle, plastic | 71335-2061-1 | Bryant Ranch Prepack | 10 May 2022 |
| 30 capsule in 1 bottle, plastic | 71335-2061-2 | Bryant Ranch Prepack | 17 March 2022 |
| 20 capsule in 1 bottle, plastic | 71335-2061-3 | Bryant Ranch Prepack | 11 December 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 28 December 1976 | 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
Clinical summary
Loperamide is an opioid agonist indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. MedsAcross supplies Loperamide 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 LoperamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Loperamide Hydrochloride prescribing information (Advagen Pharma) · U.S. National Library of Medicine, DailyMed
Need Loperamide 2 mg 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.