DRAXIMAGE DTPA
- Product NDC
- 65174-288
- 11-digit product format
- 651740288
- Labeler code
- 65174
- Product ID
- 65174-288_ea90e623-af26-4014-a0c3-3fe5d753a5e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Kit for the preparation of Technetium Tc 99m Pentetate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; RESPIRATORY (INHALATION)
- Labeler
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Application
- NDA018511
- Marketing category
- NDA
- Marketing start
- 1989-12-29
- Substance
- PENTETIC ACID
- Active strength
- 20 mg/1
- Pharmacologic classes
- Lead Chelating Activity [MoA], Lead Chelator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DRAXIMAGE DTPA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENTETIC ACID | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7A314HQM0I |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65174-288-30 | DRAXIMAGE DTPA | 30 in 1 KIT | INJECTION, POWDER, LYOPHILIZED, | 30 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65174-288 | DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] | 8 | Current NDC, Legacy NDC, 1 package rows | 20230615_becdab53-f7a7-7280-6930-21f3a61b99e7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65174-288-05 | 65174028805 | 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-05) | 1989-12-29 | 0000-00-00 | No | No | Current |
| 65174-288-30 | 65174028830 | 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30) | 1989-12-29 | 0000-00-00 | No | No | Current |