Prescription drug · ANDA

Solifenacin Succinate NDC 67877-527

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

NDC codes

FDA NDC Directory
Product NDC (as listed)67877-527Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0527Add 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
67877-527-306787705273030 TABLET, FILM COATED in 1 BOTTLE (67877-527-30)Marketed from May 21, 2019
67877-527-386787705273810 BLISTER PACK in 1 CARTON (67877-527-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-527-33)Marketed from May 21, 2019
67877-527-906787705279090 TABLET, FILM COATED in 1 BOTTLE (67877-527-90)Marketed from May 21, 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, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210224
Marketing start
Listing expires
Other FDA classes
Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 67877-527_e0e2cc86-60c8-450a-86f8-c551308ff027SPL ID e0e2cc86-60c8-450a-86f8-c551308ff027SPL set ID 97d8a21e-4618-460f-8cf5-97a9d946039eRxCUI 477367, 477372UNII KKA5DLD701UPC 0367877527307, 0367877528908
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

N467877052730 followed by a unit qualifier and the quantity

Package 67877-0527-30. 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 .

Indications (excerpt from the label)

Solifenacin succinate tablets is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets is 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 210224

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

FDA NDC Directory listings under ANDA 210224
ProductStrengthForm · routeLabelerProduct NDC
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2985
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1729
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-561
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8867
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8868
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8869
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8870
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1848
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1849
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-528

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Solifenacin Succinate NDC 67877-527 | Med-Code