Prescription drug · NDA
Ceretec NDC 17156-025
technetium tc-99m exametazime and cobaltous chloride · Kit · Medi-Physics, Inc. dba GE Healthcare
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17156-025-05 | 17156002505 | 1 KIT in 1 CARTON (17156-025-05) * 5 mL in 1 VIAL, GLASS (17156-022-05) * 2.5 mL in 1 VIAL, GLASS (17156-027-01)Marketed from Sep 25, 2018 |
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)
- Ceretec
- Generic name (nonproprietary)
- technetium tc-99m exametazime and cobaltous chloride
- Dosage form
- Kit
- Labeler
- Medi-Physics, Inc. dba GE HealthcareNDC labeler code 17156
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019829
- Marketing start
- Listing expires
- Identifiers
- Product ID 17156-025_644e5fd7-d8ee-4f20-aa05-9a11332f08c6SPL ID 644e5fd7-d8ee-4f20-aa05-9a11332f08c6SPL set ID d9c291e0-cd0d-43d2-87b4-defefd531942
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.
- NDC on a medical claim
N417156002505followed by a unit qualifier and the quantityPackage 17156-0025-05. 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)
Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ( 1.1 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. ( 1.2 ) 1.1 Leukocyte Labeled Scintigraphy Ceretec, when reconstituted with technetium Tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. 1.2 Cerebral Scintigraphy …
Excerpt only. Read the full label for complete information.
About NDC 17156-025
- What is NDC 17156-025?
- 17156-025 is the product NDC for Ceretec kit, listed with the FDA by Medi-Physics, Inc. dba GE Healthcare. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ceretec (Technetium Tc-99m Exametazime and Cobaltous Chloride).
- Who is the labeler?
- Medi-Physics, Inc. dba GE Healthcare, NDC labeler code 17156. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ceretec?
- 1 other product NDC are listed under this name. See all Ceretec NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ceretec products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ceretectechnetium tc-99m exametazime | Technetium tc-99m exametazime .5 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Medi-Physics Inc. dba GE Healthcare. | 17156-022 | 17156-0022-05 |
Other NDCs under NDA 019829
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ceretectechnetium tc-99m exametazime | Technetium tc-99m exametazime .5 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Medi-Physics Inc. dba GE Healthcare. | 17156-022 |