Solifenacin Succinate NDC 82804-044

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-044Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0044Add 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
82804-044-30	82804004430	30 TABLET, FILM COATED in 1 BOTTLE (82804-044-30)Marketed from Nov 28, 2023
82804-044-60	82804004460	60 TABLET, FILM COATED in 1 BOTTLE (82804-044-60)Marketed from Nov 28, 2023
82804-044-90	82804004490	90 TABLET, FILM COATED in 1 BOTTLE (82804-044-90)Marketed from Nov 28, 2023

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 — 5 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 211701
Marketing start: Mar 23, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 82804-044_8ab4f222-018f-40fc-a6aa-39dab563a8a0SPL ID 8ab4f222-018f-40fc-a6aa-39dab563a8a0SPL set ID 8ab4f222-018f-40fc-a6aa-39dab563a8a0RxCUI 477367UNII KKA5DLD701UPC 0382804044900
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

N482804004430 followed by a unit qualifier and the quantity

Package 82804-0044-30. 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 Nov 1, 2023.

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 211701

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

FDA NDC Directory listings under ANDA 211701
Product	Strength	Form · route	Labeler	Product NDC
Solifenacin Succinate	Solifenacin succinate 5 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-328
Solifenacin Succinate	Solifenacin succinate 10 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-329
Solifenacin Succinate	Solifenacin succinate 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-266