Prescription drug · ANDA

Paroxetine NDC 50268-642

Paroxetine hydrochloride hemihydrate 30 mg/1 · Tablet, Film coated · Oral · AvPAK

NDC codes

FDA NDC Directory
Product NDC (as listed)50268-642Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0642Add 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
50268-642-155026806421550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-642-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-642-11)Marketed from Mar 11, 2016

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)
Paroxetine
Generic name (nonproprietary)
paroxetine
Active ingredients
Paroxetine hydrochloride hemihydrate — 30 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
AvPAK
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 50268-642_4dc86e5a-77b7-8cfe-e063-6394a90a7289SPL ID 4dc86e5a-77b7-8cfe-e063-6394a90a7289SPL set ID d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43RxCUI 1738483, 1738495, 1738503, 1738511UNII 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

N450268064215 followed by a unit qualifier and the quantity

Package 50268-0642-15. 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 hydrochloride 10 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8359
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 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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Paroxetine NDC 50268-642 | Med-Code