Prescription drug · ANDA
Kit for the Preparation of Technetium Tc99m Mertiatide (Betiatide) NDC 45567-0655
Betiatide 1 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45567-0655-1 | 45567065501 | 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1)Marketed from Sep 2, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Tc99m Mertiatide
- Generic name (nonproprietary)
- betiatide
- Active ingredients
- Betiatide — 1 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 45567
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208994
- Marketing start
- Listing expires
- Identifiers
- Product ID 45567-0655_21ca1be3-2caf-535c-e063-6394a90a18e5SPL ID 21ca1be3-2caf-535c-e063-6394a90a18e5SPL set ID 0ad62039-f848-4f3d-b489-2524e6b6b86eUNII 9NV2SR34P8
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
N445567065501followed by a unit qualifier and the quantityPackage 45567-0655-01. 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)
INDICATIONS AND USAGE Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use .) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
Excerpt only. Read the full label for complete information.
About NDC 45567-0655
- What is NDC 45567-0655?
- 45567-0655 is the product NDC for Kit for the Preparation of Technetium Tc99m Mertiatide, Betiatide 1 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kit for the Preparation of Technetium Tc99m Mertiatide (Betiatide).
- What is the active ingredient?
- Betiatide.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 45567. 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 Tc99m Mertiatide?
- 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.