sirolimus NDC 16714-189

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0189Add 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
16714-189-01	16714018901	100 TABLET, FILM COATED in 1 BOTTLE (16714-189-01)Marketed from Oct 18, 2021

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): sirolimus
Generic name (nonproprietary): sirolimus
Active ingredients: Sirolimus — 2 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NORTHSTAR RX LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208691
Marketing start: Oct 18, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 16714-189_433f1406-4cb9-4ae3-bdb9-2ff4c9011e5eSPL ID 433f1406-4cb9-4ae3-bdb9-2ff4c9011e5eSPL set ID ad39eb60-1fa0-4722-8ba1-523194921c2aRxCUI 349208, 360110, 905158UNII W36ZG6FT64UPC 0316714189017, 0316714188010, 0316714187013
Pharmacologic class: Kinase Inhibitor; mTOR Inhibitor Immunosuppressant

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416714018901 followed by a unit qualifier and the quantity

Package 16714-0189-01. 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

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