Sincalide NDC 63323-579

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-579Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0579Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63323-579-05	63323057905	10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)Marketed from Apr 1, 2023

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): Sincalide
Generic name (nonproprietary): sincalide
Active ingredients: Sincalide — 5 ug/5mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 017697
Marketing start: Apr 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cholecystokinin (Chemical structure)
Identifiers: Product ID 63323-579_7aa01e72-178a-4161-b41b-f05bc8eba1a0SPL ID 7aa01e72-178a-4161-b41b-f05bc8eba1a0SPL set ID bb5057da-8568-49b9-947d-fab7d8d8f257RxCUI 237982UNII M03GIQ7Z6PUPC 0363323579012
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.

How CPT relates to drug billing

NDC on a medical claim

N463323057905 followed by a unit qualifier and the quantity

Package 63323-0579-05. 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 Jan 26, 2024.

Indications (excerpt from the label)

Sincalide for Injection 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. Sincalide for Injection is a cholecystokinin (CCK) analog…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017697

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 017697
Product	Strength	Form · route	Labeler	Product NDC
Kinevacsincalide	Sincalide 5 ug/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Bracco Diagnostics Inc.	0270-0556