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NDC 52768-0100-03 AMMONIA N-13 260 mCi/mL Details
AMMONIA N-13 260 mCi/mL
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 Information
| NDC | 52768-0100 |
|---|---|
| Product ID | 52768-100_83a25b5d-25e8-408d-89b0-a8eee42663cb |
| Associated GPIs | |
| GCN Sequence Number | 080503 |
| GCN Sequence Number Description | ammonia N-13 SYRINGE 3.75-260 INTRAVEN |
| HIC3 | A6W |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS - RADIOACTIVE |
| GCN | 47367 |
| HICL Sequence Number | 045976 |
| HICL Sequence Number Description | AMMONIA N-13 |
| Brand/Generic | Generic |
| Proprietary Name | AMMONIA N-13 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AMMONIA N-13 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 260 |
| Active Ingredient Units | mCi/mL |
| Substance Name | AMMONIA N-13 |
| Labeler Name | Precision Nuclear LLC |
| Pharmaceutical Class | Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204547 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52768-0100-03 (52768010003)
| NDC Package Code | 52768-100-03 |
|---|---|
| Billing NDC | 52768010003 |
| Package | 3 mL in 1 SYRINGE (52768-100-03) |
| Marketing Start Date | 2017-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |