NDC codes

FDA NDC Directory
Product NDC (as listed)62559-158Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0158Add 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
62559-158-016255901580162559015801100 TABLET, COATED in 1 BOTTLE (62559-158-01)Marketed from Aug 9, 2011

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)
fluvoxamine maleate
Generic name (nonproprietary)
fluvoxamine maleate
Active ingredients
Fluvoxamine maleate — 25 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021519
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 62559-158_cfb2098d-d30b-4a8e-84c1-aeb8065b519cSPL ID cfb2098d-d30b-4a8e-84c1-aeb8065b519cSPL set ID 7ecd83ec-88f5-4f85-9cc2-9068375d8820RxCUI 903884, 903887, 903891UNII 5LGN83G74VUPC 0362559159012, 0362559158015, 0362559160018
Pharmacologic class
Serotonin Reuptake Inhibitor

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

N462559015801 followed by a unit qualifier and the quantity

Package 62559-0158-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-Compulsive Disorder Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional beh…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-158

What is NDC 62559-158?
62559-158 is the product NDC for fluvoxamine maleate, Fluvoxamine maleate 25 mg/1 tablet, coated, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
fluvoxamine maleate.
What is the active ingredient?
Fluvoxamine maleate.
Who is the labeler?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for fluvoxamine maleate?
37 other product NDCs are listed under this name. See all fluvoxamine maleate 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 fluvoxamine maleate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fluvoxamine MaleateFluvoxamine maleate 150 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0832-602600832-6026-30
Fluvoxamine MaleateFluvoxamine maleate 100 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC0832-602500832-6025-30
Fluvoxamine MaleateFluvoxamine maleate 100 mg/1Capsule, Extended releaseOralAvKARE73190-06673190-0066-30
Fluvoxamine MaleateFluvoxamine maleate 150 mg/1Capsule, Extended releaseOralAvKARE73190-06773190-0067-30
Fluvoxamine maleateFluvoxamine maleate 100 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-401168788-4011-0368788-4011-0668788-4011-09
Fluvoxamine MaleateFluvoxamine maleate 100 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-06431722-0064-0131722-0064-30
Fluvoxamine MaleateFluvoxamine maleate 150 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-06531722-0065-0131722-0065-30
Fluvoxamine maleateFluvoxamine maleate 100 mg/1TabletOralA-S Medication Solutions50090-772850090-7728-00
Fluvoxamine maleateFluvoxamine maleate 25 mg/1TabletOralBionpharma Inc.69452-45469452-0454-2069452-0454-3069452-0454-32
Fluvoxamine maleateFluvoxamine maleate 100 mg/1TabletOralBionpharma Inc.69452-45569452-0455-2069452-0455-3069452-0455-32

All 38 fluvoxamine maleate NDCs

Other NDCs under NDA 021519

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

FDA NDC Directory listings under NDA 021519
ProductStrengthForm · routeLabelerProduct NDC
fluvoxamine maleateFluvoxamine maleate 100 mg/1Tablet, CoatedOralA-S Medication Solutions50090-5988
fluvoxamine maleateFluvoxamine maleate 50 mg/1Tablet, CoatedOralANI Pharmaceuticals, Inc.62559-159
fluvoxamine maleateFluvoxamine maleate 100 mg/1Tablet, CoatedOralANI Pharmaceuticals, Inc.62559-160
fluvoxamine maleateFluvoxamine maleate 100 mg/1Tablet, CoatedOralPreferred Pharmaceuticals, Inc.68788-7219
fluvoxamine maleateFluvoxamine maleate 100 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-1057
fluvoxamine maleateFluvoxamine maleate 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-1643

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