What is NDC 70511-131?

70511-131 is the product NDC for Sincalide, Sincalide 5 ug/5mL injection, powder, lyophilized, for solution, listed with the FDA by MAIA Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

MAIA Pharmaceuticals, Inc., NDC labeler code 70511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sincalide?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sincalide NDC 70511-131 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70511-131Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70511-0131Add 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
70511-131-84	7051101318470511013184	10 VIAL in 1 PACKAGE (70511-131-84) / 5 mL in 1 VIAL (70511-131-05)Marketed from Nov 25, 2022

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: MAIA Pharmaceuticals, Inc.NDC labeler code 70511
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210850
Marketing start: Nov 25, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholecystokinin (Chemical structure)
Identifiers: Product ID 70511-131_f79a9ced-87d3-4e83-af8c-1451fcec4520SPL ID f79a9ced-87d3-4e83-af8c-1451fcec4520SPL set ID 4149af34-7b3d-4200-9609-ea856b1d6aabRxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N470511013184 followed by a unit qualifier and the quantity

Package 70511-0131-84. 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 Nov 1, 2023.

Indications (excerpt from the label)

Sincalide for Injection is indicated in adults 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; stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; 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 indicate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70511-131

What is NDC 70511-131?: 70511-131 is the product NDC for Sincalide, Sincalide 5 ug/5mL injection, powder, lyophilized, for solution, listed with the FDA by MAIA Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sincalide.
What is the active ingredient?: Sincalide.
Who is the labeler?: MAIA Pharmaceuticals, Inc., NDC labeler code 70511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sincalide?: 2 other product NDCs are listed under this name. See all Sincalide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sincalide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sincalide	Sincalide 5 ug/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-579	63323-0579-05
Sincalide	Sincalide 5 ug/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	FOSUN PHARMA USA INC	72266-248	72266-0248-05

Other NDCs under NDA 210850

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

FDA NDC Directory listings under NDA 210850
Product	Strength	Form · route	Labeler	Product NDC
Sincalide	Sincalide 5 ug/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	FOSUN PHARMA USA INC	72266-248