NDC 76451-013
Ammonia N 13
Ammonia N-13
Ammonia N 13 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by 3d Imaging Drug Design And Development Llc. The primary component is Ammonia N-13.
| Product ID | 76451-013_7e8813c2-f881-4543-83d5-c9c8614f782e |
| NDC | 76451-013 |
| 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 | 2018-12-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203779 |
| Labeler Name | 3D Imaging Drug Design and Development LLC |
| 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 | 2020-12-31 |
Packaging
NDC 76451-013-10
10 mL in 1 VIAL, GLASS (76451-013-10)
| Marketing Start Date | 2018-12-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 76451-013-11 [76451001311]
Ammonia N 13 INJECTION
| Marketing Category | ANDA |
| Application Number | ANDA203779 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-17 |
NDC 76451-013-51 [76451001351]
Ammonia N 13 INJECTION
| Marketing Category | ANDA |
| Application Number | ANDA203779 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-17 |
NDC 76451-013-10 [76451001310]
Ammonia N 13 INJECTION
| Marketing Category | ANDA |
| Application Number | ANDA203779 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-17 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| AMMONIA N-13 | 37.5 mCi/mL |
OpenFDA Data
| SPL SET ID: | fce62c22-a1e2-4193-8de5-e1961d9b94a5 |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radioactive Diagnostic Agent [EPC]
- Radiopharmaceutical Activity [MoA]
- Radioactive Diagnostic Agent [EPC]
- Radiopharmaceutical Activity [MoA]
NDC Crossover Matching brand name "Ammonia N 13" or generic name "Ammonia N-13"
| 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 |
| 71162-001 | Ammonia N 13 | Ammonia N 13 |
| 75913-113 | Ammonia N 13 | Ammonia N 13 |
| 76318-643 | Ammonia N 13 | Ammonia N 13 |
| 76394-3812 | Ammonia N 13 | Ammonia N 13 |
| 76451-013 | Ammonia N 13 | Ammonia N 13 |
| 73410-001 | Ammonia N 13 | Ammonia N 13 |
| 70681-001 | Ammonia N 13 | Ammonia N 13 |
| 72333-001 | 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 |
| 24450-113 | AMMONIA N-13 | AMMONIA N-13 |
| 52768-100 | AMMONIA N-13 | AMMONIA N-13 |
Trademark Results [Ammonia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMMONIA 75057807 2116798 Dead/Cancelled |
Ammonia 1996-02-14 |
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