Prescription drug · ANDA
Kit for the Preparation of Technetium Tc 99m Pentetate NDC 69945-314
Pentetic acid 20 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous, Respiratory (Inhalation) · Curium US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69945-314-05 | 6994503140569945031405 | 5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01)Marketed from Apr 8, 2025 | |
| 69945-314-30 | 6994503143069945031430 | 30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01)Marketed from Apr 8, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Kit for the Preparation of Technetium Tc 99m Pentetate
- Generic name (nonproprietary)
- kit for the preparation of technetium tc 99m pentetate
- Active ingredients
- Pentetic acid — 20 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous, Respiratory (Inhalation)
- Labeler
- Curium US LLCNDC labeler code 69945
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215146
- Marketing start
- Listing expires
- Other FDA classes
- Lead Chelating Activity (Mechanism)
- Identifiers
- Product ID 69945-314_3153807a-9849-8e8b-e063-6294a90a7c34SPL ID 3153807a-9849-8e8b-e063-6294a90a7c34SPL set ID 59b3b7d5-ff69-4642-971e-99026d9dce89UNII 7A314HQM0I
- Pharmacologic class
- Lead Chelator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N469945031405followed by a unit qualifier and the quantityPackage 69945-0314-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for Kit for the Preparation of Technetium Tc 99m Pentetate Injection. Technetium Tc 99m pentetate is a radioactive diagnostic agent indicated for: Brain imaging in adults ( 1.1 ). Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients ( 1.2 ). Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients ( 1.3 ). 1.1 Brain Imaging Brain imaging in adults by intravenous administration. 1.2 Renal Scintigraphy Renal visualization, asse…
Excerpt only. Read the full label for complete information.
About NDC 69945-314
- What is NDC 69945-314?
- 69945-314 is the product NDC for Kit for the Preparation of Technetium Tc 99m Pentetate, Pentetic acid 20 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Curium US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kit for the Preparation of Technetium Tc 99m Pentetate.
- What is the active ingredient?
- Pentetic acid.
- Who is the labeler?
- Curium US LLC, NDC labeler code 69945. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kit for the Preparation of Technetium Tc 99m Pentetate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.