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NDC 71162-0001-10 Ammonia N 13 37.5 mCi/mL Details
Ammonia N 13 37.5 mCi/mL
Ammonia N 13 is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ionetix Corporation. The primary component is AMMONIA N-13.
Product Information
| NDC | 71162-0001 |
|---|---|
| Product ID | 71162-001_0bc8add0-810a-3d43-e063-6294a90a1bb8 |
| Associated GPIs | 94353013002020 |
| GCN Sequence Number | 083609 |
| GCN Sequence Number Description | ammonia N-13 SYRINGE 3.75-37.5 INTRAVEN |
| HIC3 | A6W |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS - RADIOACTIVE |
| GCN | 52606 |
| 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 |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 37.5 |
| Active Ingredient Units | mCi/mL |
| Substance Name | AMMONIA N-13 |
| Labeler Name | Ionetix Corporation |
| Pharmaceutical Class | Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210524 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71162-0001-10 (71162000110)
| NDC Package Code | 71162-001-10 |
|---|---|
| Billing NDC | 71162000110 |
| Package | 1 VIAL, GLASS in 1 CONTAINER (71162-001-10) / 10 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2018-12-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |