Darifenacin NDC 16571-768

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-768Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0768Add 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
16571-768-03	16571076803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-03)Marketed from Sep 19, 2016
16571-768-09	16571076809	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-09)Marketed from Sep 19, 2016

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): Darifenacin
Generic name (nonproprietary): darifenacin
Active ingredients: Darifenacin hydrobromide — 15 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206743
Marketing start: Sep 19, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 16571-768_fd55c56a-79a8-4830-92d7-19f62bee0b5fSPL ID fd55c56a-79a8-4830-92d7-19f62bee0b5fSPL set ID e2aa9544-0136-463d-a73b-1a299534446aRxCUI 485421, 485423UNII CR02EYQ8GVUPC 0316571767038
Pharmacologic class: Cholinergic Muscarinic Antagonist

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

N416571076803 followed by a unit qualifier and the quantity

Package 16571-0768-03. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.