Solifenacin succinate NDC 82804-058

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-058Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0058Add 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
82804-058-30	82804005830	30 TABLET, FILM COATED in 1 BOTTLE (82804-058-30)Marketed from Jan 15, 2024
82804-058-60	82804005860	60 TABLET, FILM COATED in 1 BOTTLE (82804-058-60)Marketed from Jan 15, 2024
82804-058-90	82804005890	90 TABLET, FILM COATED in 1 BOTTLE (82804-058-90)Marketed from Jan 15, 2024

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): Solifenacin succinate
Generic name (nonproprietary): solifenacin succinate
Active ingredients: Solifenacin succinate — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202551
Marketing start: Apr 9, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 82804-058_b20003a6-f781-4563-9824-3e8b97c763c6SPL ID b20003a6-f781-4563-9824-3e8b97c763c6SPL set ID b20003a6-f781-4563-9824-3e8b97c763c6RxCUI 477372UNII KKA5DLD701UPC 0382804058303
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

N482804005830 followed by a unit qualifier and the quantity

Package 82804-0058-30. 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 1, 2024.

Indications (excerpt from the label)

Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202551

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

FDA NDC Directory listings under ANDA 202551
Product	Strength	Form · route	Labeler	Product NDC
Solifenacin succinate	Solifenacin succinate 5 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0591-3795
Solifenacin succinate	Solifenacin succinate 10 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0591-3796