Kit for the Preparation of Technetium Tc 99m Pentetate
- Product NDC
- 69945-314
- 11-digit product format
- 699450314
- Labeler code
- 69945
- Product ID
- 69945-314_3153807a-9849-8e8b-e063-6294a90a7c34
- 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
- Curium US LLC
- Application
- ANDA215146
- Marketing category
- ANDA
- Marketing start
- 2025-04-08
- Substance
- PENTETIC ACID
- Active strength
- 20 mg/mL
- 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
- Kit for the Preparation of Technetium Tc 99m Pentetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENTETIC ACID | 20 mg/mL |
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 |
|---|
| 69945-314-01 | Kit for the Preparation of Technetium Tc 99m Pentetate | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
| 69945-314-05 | Kit for the Preparation of Technetium Tc 99m Pentetate | 5 in 1 KIT | INJECTION, POWDER, LYOPHILIZED, | 5 | | 1 |
| 69945-314-30 | Kit for the Preparation of Technetium Tc 99m Pentetate | 30 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69945-314 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CURIUM US LLC] | 1 | Current NDC, 3 package rows | 20250409_59b3b7d5-ff69-4642-971e-99026d9dce89.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69945-314-01 | 69945031401 | 10 mL in 1 VIAL | 10 ml | | | | Historical |
| 69945-314-05 | 69945031405 | 5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01) | 5 vial | 2025-04-08 | No | No | Historical |
| 69945-314-30 | 69945031430 | 30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01) | 30 vial | 2025-04-08 | No | No | Historical |