Solifenacin Succinate NDC 46708-192

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-192Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0192Add 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
46708-192-08	46708019208	80 TABLET, COATED in 1 CARTON (46708-192-08)Marketed from May 20, 2019
46708-192-30	46708019230	30 TABLET, COATED in 1 BOTTLE (46708-192-30)Marketed from May 20, 2019
46708-192-90	46708019290	90 TABLET, COATED in 1 BOTTLE (46708-192-90)Marketed from May 20, 2019
46708-192-91	46708019291	1000 TABLET, COATED in 1 BOTTLE (46708-192-91)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 succinate
Active ingredients: Solifenacin succinate — 5 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205575
Marketing start: May 20, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 46708-192_aea71cde-6d62-4f8d-b813-47064cb213d9SPL ID aea71cde-6d62-4f8d-b813-47064cb213d9SPL set ID aea71cde-6d62-4f8d-b813-47064cb213d9RxCUI 477367, 477372UNII KKA5DLD701UPC 0346708193300
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

N446708019208 followed by a unit qualifier and the quantity

Package 46708-0192-08. 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 22, 2019.

Indications (excerpt from the label)

Solifenacin succinate tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are muscarinic antagonist indicated for the treatment of 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 205575

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

FDA NDC Directory listings under ANDA 205575
Product	Strength	Form · route	Labeler	Product NDC
Solifenacin Succinate	Solifenacin succinate 10 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-193
Solifenacin Succinate	Solifenacin succinate 5 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-192
Solifenacin Succinate	Solifenacin succinate 10 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-193