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NDC 65174-0288-30 DRAXIMAGE DTPA 20 mg/1 Details
DRAXIMAGE DTPA 20 mg/1
DRAXIMAGE DTPA is a INTRAVENOUS; RESPIRATORY (INHALATION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Jubilant DraxImage Inc., dba Jubilant Radiopharma. The primary component is PENTETIC ACID.
Product Information
| NDC | 65174-0288 |
|---|---|
| Product ID | 65174-288_ea90e623-af26-4014-a0c3-3fe5d753a5e6 |
| Associated GPIs | |
| GCN Sequence Number | 067757 |
| GCN Sequence Number Description | kit prep Tc 99m/pentetic acid VIAL 20 MG INTRAVEN |
| HIC3 | Z9D |
| HIC3 Description | DIAGNOSTIC PREPARATIONS,MISCELLANEOUS |
| GCN | 30377 |
| HICL Sequence Number | 037857 |
| HICL Sequence Number Description | KIT FOR THE PREPARATION OF TC-99M/PENTETIC ACID |
| Brand/Generic | Brand |
| Proprietary Name | DRAXIMAGE DTPA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Kit for the preparation of Technetium Tc 99m Pentetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS; RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | PENTETIC ACID |
| Labeler Name | Jubilant DraxImage Inc., dba Jubilant Radiopharma |
| Pharmaceutical Class | Lead Chelating Activity [MoA], Lead Chelator [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA018511 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65174-0288-30 (65174028830)
| NDC Package Code | 65174-288-30 |
|---|---|
| Billing NDC | 65174028830 |
| Package | 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30) |
| Marketing Start Date | 1989-12-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |