Ammonia N 13 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Global Isotopes, Llc D/b/a Zevacor Molecular. The primary component is Ammonia N-13.
| Product ID | 69126-001_5d8e94f9-8c33-e3cb-e053-2a91aa0a84e1 |
| NDC | 69126-001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ammonia N 13 |
| Generic Name | Ammonia N 13 |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2014-10-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204465 |
| Labeler Name | Global Isotopes, LLC d/b/a Zevacor Molecular |
| Substance Name | AMMONIA N-13 |
| Active Ingredient Strength | 38 mCi/mL |
| Pharm Classes | Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2014-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204465 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-10-31 |
| Marketing End Date | 2019-05-17 |
| Ingredient | Strength |
|---|---|
| AMMONIA N-13 | 37.5 mCi/mL |
| SPL SET ID: | 967407b9-621e-4165-a245-11bf577497d6 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13108-311 | Ammonia N 13 | Ammonia N 13 |
| 13267-456 | Ammonia N 13 | NH3N13 |
| 24275-0385 | Ammonia N 13 | NH3N13 |
| 24445-643 | Ammonia N 13 | AMMONIA N-13 |
| 24562-004 | Ammonia N 13 | Ammonia N-13 |
| 40028-513 | Ammonia N 13 | Ammonia N-13 |
| 40089-113 | Ammonia N 13 | NH3N13 |
| 44338-002 | Ammonia N 13 | Ammonia N-13 |
| 49609-201 | Ammonia N 13 | Ammonia N-13 |
| 51760-003 | Ammonia N 13 | NH3N13 |
| 52670-552 | Ammonia N 13 | ammonia n-13 |
| 69126-001 | Ammonia N 13 | Ammonia N 13 |
| 69714-001 | Ammonia N 13 | NH3N13 |
| 71162-001 | Ammonia N 13 | Ammonia N-13 |
| 72333-001 | Ammonia N 13 | Ammonia N 13 |
| 73410-001 | Ammonia N 13 | Ammonia N 13 |
| 75913-113 | Ammonia N 13 | NH3N13 |
| 76318-643 | Ammonia N 13 | Ammonia N 13 |
| 76394-3812 | Ammonia N 13 | Ammonia N 13 |
| 76451-013 | Ammonia N 13 | Ammonia N 13 |
| 16129-003 | Ammonia N 13 | Ammonia N 13 |
| 47584-003 | Ammonia N 13 | Ammonia N 13 |
| 62072-456 | Ammonia N 13 | Ammonia N 13 |
| 70681-001 | Ammonia N 13 | Ammonia N 13 |
| 49609-003 | Ammonia N 13 | Ammonia N 13 |