Medicine
Ammonia n-13 37.5 mCi/mL injection
Ammonia n-13 37.5 mCi/mL injection is a generic prescription medicine for intravenous use, made by 15 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°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Ammonia n-13
- Brand
- Sold under the generic name
- Strength
- 37.5 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 mL, 30 mL, 8 mL and 12 more
- Manufacturers
- 3D Imaging Drug Design and DevelopmentBiomedical Research Foundation of Northwest LouisianaBrigham and Women's Hospital, Inc., TheCardinal HealthIonetixKreitchman PET CenterMassachusetts General HospitalMayo ClinicSofieThe Feinstein Institutes for Medical Research
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 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 a4a2bb1a-1ecc-48e4-a87b-60fc583f61ce, af70d0da-1c2d-44e4-b4cd-7cce6636c7b9, e901d193-527d-4e39-8727-c152b56fb9e2 +12NDC 24562-004, 52670-552, 70681-001 +12Application ANDA204352, ANDA203321, ANDA209507 +12
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 |
|---|---|---|---|
| 10 mL in 1 vial, glass | 76451-013-10 | 3D Imaging Drug Design and Development | 17 December 2018 |
| 30 mL in 1 vial, glass | 24562-004-30 | Biomedical Research Foundation of Northwest Louisiana | 14 May 2015 |
| 10 mL in 1 vial, glass | 24450-113-10 | Brigham and Women's Hospital, Inc., The | 1 November 2014 |
| 8 mL in 1 vial, glass | 13267-456-56 | The Feinstein Institutes for Medical Research | 23 August 2007 |
| 5 mL in 1 syringe, plastic | 71162-001-05 | Ionetix | 31 January 2020 |
| 20 mL in 1 vial, glass | 40089-113-20 | The Johns Hopkins University | 21 March 2012 |
| 8 mL in 1 vial, glass | 62072-456-56 | Kreitchman PET Center | 9 December 2013 |
| 30 mL in 1 vial | 76318-643-30 | Massachusetts General Hospital | 3 February 2016 |
| 30 mL in 1 vial, single-dose | 52670-552-30 | Mayo Clinic | 25 February 2013 |
| 30 mL in 1 vial, multi-dose | 73410-001-01 | Sofie | 6 November 2019 |
| 10 mL in 1 vial, glass | 24275-0385-1 | UCSF Radiopharmaceutical Facility | 6 November 2008 |
| 30 mL in 1 vial, glass | 70681-001-30 | The University of Texas Southwestern Medical Center | 1 May 2020 |
| 1 vial, glass in 1 container / 10 mL in 1 vial, glass | 72333-001-10 | University of Wisconsin System | 9 September 2020 |
| 10 mL in 1 vial, glass | 75913-113-10 | Washington University School of Medicine | 20 March 2012 |
| 10 mL in 1 vial, glass | 65857-200-10 | Cardinal Health | 25 February 2013 |
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 37.5 mCi/mL injection for your hospital or patient?
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