Solifenacin succinate NDC 0591-3795

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-3795Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-3795Add 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
0591-3795-19	00591379519	90 TABLET, FILM COATED in 1 BOTTLE (0591-3795-19)Marketed from Jun 30, 2020
0591-3795-30	00591379530	30 TABLET, FILM COATED in 1 BOTTLE (0591-3795-30)Marketed from Jan 23, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202551
Marketing start: Jun 30, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0591-3795_4a8ad4ea-e579-4269-b16d-fdc627ba1114SPL ID 4a8ad4ea-e579-4269-b16d-fdc627ba1114SPL set ID 02e2aa54-1ed8-445a-a082-ac2c64b339feRxCUI 477367, 477372UNII KKA5DLD701UPC 0305913796300, 0305913795303
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

N400591379519 followed by a unit qualifier and the quantity

Package 00591-3795-19. 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 28, 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 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 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-058
Solifenacin succinate	Solifenacin succinate 10 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0591-3796