Solifenacin Succinate NDC 65862-878

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-878Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0878Add 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
65862-878-03	65862087803	3 BLISTER PACK in 1 CARTON (65862-878-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-878-10)Marketed from Dec 27, 2022
65862-878-30	65862087830	30 TABLET, FILM COATED in 1 BOTTLE (65862-878-30)Marketed from Dec 27, 2022
65862-878-90	65862087890	90 TABLET, FILM COATED in 1 BOTTLE (65862-878-90)Marketed from Dec 27, 2022
65862-878-99	65862087899	1000 TABLET, FILM COATED in 1 BOTTLE (65862-878-99)Marketed from Dec 27, 2022

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: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206817
Marketing start: Dec 27, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 65862-878_ececaabb-2b01-4ef5-b5e8-a927478decccSPL ID ececaabb-2b01-4ef5-b5e8-a927478decccSPL set ID 92b37f2d-b1cf-49e6-a13b-0ead92c0604cRxCUI 477367, 477372UNII KKA5DLD701UPC 0365862879301, 0365862878304
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

N465862087803 followed by a unit qualifier and the quantity

Package 65862-0878-03. 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

Current FDA label (SPL), effective May 9, 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 206817

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

FDA NDC Directory listings under ANDA 206817
Product	Strength	Form · route	Labeler	Product NDC
Solifenacin Succinate	Solifenacin succinate 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-879