Medicine
Nizatidine 150 mg capsule
Nizatidine 150 mg capsule is a generic prescription medicine for oral use, made by 3 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)
- Nizatidine
- Brand
- Sold under the generic name
- Strength
- 150 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 5 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaEpic PharmaActavis Pharma
- 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
- A02BA04 Nizatidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 July 2002
- Identifiers
- RxCUI 198041, 312025DailyMed set ID 367a1004-59c1-4474-a4f6-ce8bf5a1b043, faaa7cc4-fda9-d5b8-de2a-71c8744ccb76, e9957997-8b85-48a0-9bb3-b878cb223236NDC 0591-3137, 55111-310, 42806-299Application ANDA075616, ANDA077314, ANDA076178
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 55111-310-01 | Dr. Reddy's LaboratoriesIndia | 15 September 2005 |
| 500 capsule in 1 bottle | 55111-310-05 | Dr. Reddy's LaboratoriesIndia | 15 September 2005 |
| 30 capsule in 1 bottle | 55111-310-30 | Dr. Reddy's LaboratoriesIndia | 15 September 2005 |
| 60 capsule in 1 bottle | 55111-310-60 | Dr. Reddy's LaboratoriesIndia | 15 September 2005 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 55111-310-78 | Dr. Reddy's LaboratoriesIndia | 15 September 2005 |
| 60 capsule in 1 bottle, plastic | 0591-3137-60 | Actavis Pharma | 9 July 2002 |
| 30 capsule in 1 bottle | 42806-299-30 | Epic Pharma | 25 October 2024 |
| 60 capsule in 1 bottle | 42806-299-60 | Epic Pharma | 25 October 2024 |
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 12 April 1988 | 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
Other strengths and forms of Nizatidine
Clinical summary
Nizatidine is a histamine-2 receptor antagonist indicated for up to 8 weeks for the treatment of active duodenal ulcer, among other approved uses. It is available as capsules and oral solution. MedsAcross supplies Nizatidine 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 NizatidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nizatidine prescribing information (Epic Pharma) · U.S. National Library of Medicine, DailyMed
Need Nizatidine 150 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.