Medicine
Ammonia n-13 260 mCi/mL injection
Ammonia n-13 260 mCi/mL injection is a generic prescription medicine for intravenous use, made by 4 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)
- Ammonia n-13
- Brand
- Sold under the generic name
- Strength
- 260 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 6 mL, 50 mL, 3 mL and 4 more
- Manufacturers
- Precision NuclearPETNET SolutionsSofieThe Methodist Hospital Research Institute
- 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 August 2007
- Identifiers
- DailyMed set ID 85882893-0661-46c2-a5f2-a73f6ea4fb5a, cc430bfd-6940-41ca-bda4-6d29eb4dc1f2, c79222b1-7dd8-f1fe-e053-2a95a90a3639 +1NDC 49609-003, 52768-100, 69864-002 +1Application ANDA203543, ANDA204547, ANDA215083 +1
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 |
|---|---|---|---|
| 6 mL in 1 vial, glass | 69864-002-30 | The Methodist Hospital Research Institute | 9 July 2021 |
| 50 mL in 1 vial, glass | 40028-514-50 | PETNET Solutions | 1 February 2025 |
| 3 mL in 1 syringe | 52768-100-03 | Precision Nuclear | 1 October 2017 |
| 5 mL in 1 syringe | 52768-100-05 | Precision Nuclear | 1 October 2017 |
| 30 mL in 1 vial, multi-dose | 52768-100-30 | Precision Nuclear | 10 October 2010 |
| 50 mL in 1 vial, multi-dose | 52768-100-50 | Precision Nuclear | 10 October 2010 |
| 30 mL in 1 vial, glass | 49609-003-01 | Sofie | 4 August 2011 |
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 23 August 2007 | 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 Ammonia n-13
Clinical summary
Ammonia n-13 is a radioactive diagnostic agent. It is available as injection for intravenous use. MedsAcross supplies Ammonia n-13 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 Ammonia n-13For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ammonia N 13 prescribing information (The Feinstein Institutes for Medical Research) · U.S. National Library of Medicine, DailyMed
Need Ammonia n-13 260 mCi/mL injection 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.