NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8870Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8870Add 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
63629-8870-1636298870016362988700190 TABLET, FILM COATED in 1 BOTTLE (63629-8870-1)Marketed from Sep 30, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
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 63629-8870_54e93c57-fe3c-4578-9048-7957281e8e5aSPL ID 54e93c57-fe3c-4578-9048-7957281e8e5aSPL set ID 2462e9a4-66a7-4340-9a81-617f3417b495RxCUI 477372UNII KKA5DLD701
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

N463629887001 followed by a unit qualifier and the quantity

Package 63629-8870-01. 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)

About NDC 63629-8870

What is NDC 63629-8870?
63629-8870 is the product NDC for Solifenacin Succinate, Solifenacin succinate 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Solifenacin Succinate.
What is the active ingredient?
Solifenacin succinate.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Solifenacin Succinate?
50 other product NDCs are listed under this name. See all Solifenacin Succinate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Solifenacin Succinate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Solifenacin succinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-083172303-0831-0172303-0831-02
Solifenacin succinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-083272303-0832-0172303-0832-02
solifenacin succinateSolifenacin succinate 5 mg/1Tablet, CoatedOralMacleods Pharmaceuticals Limited33342-14833342-0148-0733342-0148-10
solifenacin succinateSolifenacin succinate 10 mg/1Tablet, CoatedOralMacleods Pharmaceuticals Limited33342-14933342-0149-0733342-0149-10
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-87865862-0878-0365862-0878-3065862-0878-90+1 more
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-87965862-0879-0365862-0879-3065862-0879-90+1 more
solifenacin succinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-02731722-0027-3031722-0027-3131722-0027-90
solifenacin succinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-02831722-0028-3031722-0028-3131722-0028-90
Solifenacin Succinatesolifenacin succiateSolifenacin succinate 5 mg/1Tablet, Film coatedOralAvKARE42291-73942291-0739-3042291-0739-90
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralAvKARE42291-74042291-0740-3042291-0740-90

All 51 Solifenacin Succinate NDCs

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 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 5 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-527
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-528
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-561
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1729
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2985
Solifenacin SuccinateSolifenacin succinate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1848
Solifenacin SuccinateSolifenacin succinate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1849

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