Prescription drug · ANDA

Paroxetine NDC 0615-8359

Paroxetine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8359Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8359Add 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
0615-8359-390061583593930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8359-39)Marketed from Nov 11, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Paroxetine
Generic name (nonproprietary)
paroxetine
Active ingredients
Paroxetine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078406
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 0615-8359_d04ea3ee-ed50-48ca-8226-fb2d029053f3SPL ID d04ea3ee-ed50-48ca-8226-fb2d029053f3SPL set ID 0a8a58c7-5008-4c65-ae0e-e4ee809b1807RxCUI 1738483UNII X2ELS050D8
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

N400615835939 followed by a unit qualifier and the quantity

Package 00615-8359-39. 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)

INDICATIONS AND USAGE Major Depressive Disorder Paroxetine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078406

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

FDA NDC Directory listings under ANDA 078406
ProductStrengthForm · routeLabelerProduct NDC
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-056
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-184
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-181
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 20 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-182
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-183
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralAvPAK50268-640
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralAvPAK50268-642
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAvPAK50268-643
ParoxetineParoxetine hydrochloride hemihydrate 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-713
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-154
ParoxetineParoxetine hydrochloride hemihydrate 20 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-155
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-156
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-157
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2574
ParoxetineParoxetine hydrochloride hemihydrate 20 mg/1Tablet, Film coatedOralProficient Rx LP63187-564
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-157
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-154
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-155
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-156

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