Prescription drug · ANDA

Solifenacin Succinate (solifenacin succiate) NDC 35561-285

Solifenacin succinate 5 mg/1 · Tablet, Film coated · Oral · Bostal LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)35561-285Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35561-0285Add 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 NDC11-digit (billing)PackageCopy
35561-285-0035561028500256410 TABLET, FILM COATED in 1 BOX (35561-285-00)Marketed from May 20, 2019
35561-285-103556102851030 TABLET, FILM COATED in 1 BOTTLE (35561-285-10)Marketed from May 20, 2019
35561-285-113556102851190 TABLET, FILM COATED in 1 BOTTLE (35561-285-11)Marketed from May 20, 2019
35561-285-1335561028513500 TABLET, FILM COATED in 1 BOTTLE (35561-285-13)Marketed from May 20, 2019

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 succiate
Active ingredients
Solifenacin succinate — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bostal LLC
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210281
Marketing start
Listing expires
Other FDA classes
Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 35561-285_49fcc8a4-31aa-6975-e063-6394a90a9389SPL ID 49fcc8a4-31aa-6975-e063-6394a90a9389SPL set ID d155c739-6870-4938-ba91-8c1b4b90afe4RxCUI 477367, 477372UNII KKA5DLD701UPC 0335561286137, 0335561285130
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

N435561028500 followed by a unit qualifier and the quantity

Package 35561-0285-00. 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 .

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 210281

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

FDA NDC Directory listings under ANDA 210281
ProductStrengthForm · routeLabelerProduct NDC
Solifenacin Succinatesolifenacin succiateSolifenacin succinate 5 mg/1Tablet, Film coatedOralAvKARE42291-739
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralAvKARE42291-740
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralBostal LLC35561-286

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Solifenacin Succinate (solifenacin succiate) NDC 35561-285 | Med-Code