The short version
8 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Ammonia N 13
Ammonia N-13 · AMMONIA N-13 260 mCi/mL · Injection · Intravenous · SOFIE Co. dba SOFIE
NDC 49609-0003-01 · 30 mL in 1 VIAL, GLASS · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- SOFIE Co. dba SOFIEUnited Statespositron emission tomography drug production
- SOFIE Co. dba SOFIEUnited Statespositron emission tomography drug production
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA203543
- TE code
- AP
- Approval date
- Dec 14, 2012
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Ammonia N-13 (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| 3D Imaging Drug Design and Development LLC | AMMONIA N-13 37.5 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| Brigham and Women's Hospital, Inc., The | AMMONIA N-13 37.5 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| Cardinal Health 414, LLC | AMMONIA N-13 37.5 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| Ionetix Corporation | AMMONIA N-13 37.5 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| Kreitchman PET Center | AMMONIA N-13 37.5 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| PETNET Solutions, Inc. | AMMONIA N-13 260 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| SOFIE Co. dba SOFIE | AMMONIA N-13 260 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
| The Methodist Hospital Research Institute | AMMONIA N-13 260 mCi/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Ammonia N 13 — NDC 49609-0003-01," retrieved September 3, 2026, https://drugdashboards.com/drug/49609000301.
Free to cite with attribution — see how the data is put together.