AMMONIA N-13 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Precision Nuclear Llc. The primary component is Ammonia N-13.
| Product ID | 52768-100_6de43ff0-9695-89f5-e053-2991aa0a50d5 |
| NDC | 52768-100 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AMMONIA N-13 |
| Generic Name | Ammonia N-13 |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2010-10-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204547 |
| Labeler Name | Precision Nuclear LLC |
| Substance Name | AMMONIA N-13 |
| Active Ingredient Strength | 260 mCi/mL |
| Pharm Classes | Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2017-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204547 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-10-10 |
| Marketing Category | ANDA |
| Application Number | ANDA204547 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-10-10 |
| Marketing End Date | 2011-11-17 |
| Marketing Category | ANDA |
| Application Number | ANDA204547 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Marketing Category | ANDA |
| Application Number | ANDA204547 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-10-10 |
| Marketing End Date | 2011-11-17 |
| Marketing Category | ANDA |
| Application Number | ANDA204547 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-10-10 |
| Marketing Category | ANDA |
| Application Number | ANDA204547 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Ingredient | Strength |
|---|---|
| AMMONIA N-13 | 260 mCi/mL |
| SPL SET ID: | cc430bfd-6940-41ca-bda4-6d29eb4dc1f2 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 24450-113 | AMMONIA N-13 | AMMONIA N-13 |
| 52768-100 | AMMONIA N-13 | AMMONIA N-13 |
| 69864-002 | Ammonia N-13 | Ammonia N-13 |
| 16129-003 | Ammonia | AMMONIA N-13 |
| 47584-003 | Ammonia | AMMONIA N-13 |
| 49609-003 | Ammonia | AMMONIA N-13 |
| 62072-456 | Ammonia | AMMONIA N-13 |
| 65857-200 | Ammonia | Ammonia N-13 |
| 70681-001 | Ammonia | AMMONIA N-13 |
| 24445-643 | Ammonia N 13 | AMMONIA N-13 |
| 24562-004 | Ammonia N 13 | Ammonia N-13 |
| 40028-513 | Ammonia N 13 | Ammonia N-13 |
| 44338-002 | Ammonia N 13 | Ammonia N-13 |
| 49609-201 | Ammonia N 13 | Ammonia N-13 |
| 52670-552 | Ammonia N 13 | ammonia n-13 |
| 71162-001 | Ammonia N 13 | Ammonia N-13 |
| 76318-643 | Ammonia N 13 | ammonia n-13 |
| 76394-3812 | Ammonia N 13 | AMMONIA N-13 |
| 76167-003 | AmmoniaN 13 | AMMONIA N-13 |