Prescription drug · NDA
Kinevac (sincalide) NDC 0270-0556
Sincalide 5 ug/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Bracco Diagnostics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0270-0556-15 | 00270055615 | 10 VIAL in 1 PACKAGE (0270-0556-15) / 5 mL in 1 VIALMarketed from Jul 21, 1976 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Kinevac
- Generic name (nonproprietary)
- sincalide
- Active ingredients
- Sincalide — 5 ug/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Bracco Diagnostics Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017697
- Marketing start
- Listing expires
- Other FDA classes
- Cholecystokinin (Chemical structure)
- Identifiers
- Product ID 0270-0556_0d2aa8b3-2d00-f50a-c4cc-92748288e6aaSPL ID 0d2aa8b3-2d00-f50a-c4cc-92748288e6aaSPL set ID 1408aabb-6982-48e5-ae9f-504ec43b0003RxCUI 208236, 237982UNII M03GIQ7Z6P
- Pharmacologic class
- Cholecystokinin Analog
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
N400270055615followed by a unit qualifier and the quantityPackage 00270-0556-15. 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)
Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. Kinevac is a cholecystokinin (CCK) analog indicated in adults to: stimula…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 017697
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 |
|---|---|---|---|---|
| Sincalide | Sincalide 5 ug/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-579 |