Darifenacin (darifenacin hydrobromide) NDC 69097-431

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0431Add 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
69097-431-02	69097043102	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-02)Marketed from Sep 1, 2016
69097-431-05	69097043105	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-05)Marketed from Sep 1, 2016
69097-431-15	69097043115	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-15)Marketed from Sep 1, 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 hydrobromide
Active ingredients: Darifenacin hydrobromide — 7.5 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207664
Marketing start: Sep 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 69097-431_99ca2704-b757-4f10-be5c-bd01dff69b10SPL ID 99ca2704-b757-4f10-be5c-bd01dff69b10SPL set ID 6e8470d1-c3e6-4644-b70a-aa47ddf79676RxCUI 485421, 485423UNII CR02EYQ8GV
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

N469097043102 followed by a unit qualifier and the quantity

Package 69097-0431-02. 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 Oct 27, 2025.

Indications (excerpt from the label)

Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 ) Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207664

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

FDA NDC Directory listings under ANDA 207664
Product	Strength	Form · route	Labeler	Product NDC
Darifenacindarifenacin hydrobromide	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Cipla USA Inc.	69097-432