Prescription drug · ANDA
Kit for the Preparation of Technetium Tc 99m Mebrofenin NDC 45567-0455
Mebrofenin 45 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45567-0455-1 | 4556704550145567045501 | 5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 29, 2008 | |
| 45567-0455-2 | 4556704550245567045502 | 30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 29, 2008 |
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 Tc 99m Mebrofenin
- Generic name (nonproprietary)
- kit for the preparation of technetium tc 99m mebrofenin
- Active ingredients
- Mebrofenin — 45 mg/10mL
- 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 078242
- Marketing start
- Listing expires
- Identifiers
- Product ID 45567-0455_20bf6038-c480-0b7f-e063-6394a90a8d65SPL ID 20bf6038-c480-0b7f-e063-6394a90a8d65SPL set ID 11492bd5-2ade-4eb4-a23c-b9be99c0d51aUNII 7PV0B6ED98
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
N445567045501followed by a unit qualifier and the quantityPackage 45567-0455-01. 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 Mebrofenin is indicated as a hepatobiliary imaging agent.
Excerpt only. Read the full label for complete information.
About NDC 45567-0455
- What is NDC 45567-0455?
- 45567-0455 is the product NDC for Kit for the Preparation of Technetium Tc 99m Mebrofenin, Mebrofenin 45 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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 Mebrofenin.
- What is the active ingredient?
- Mebrofenin.
- 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 Tc 99m Mebrofenin?
- 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.