NDC codes

FDA NDC Directory
Product NDC (as listed)13107-155Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13107-0155Add 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
13107-155-011310701550113107015501100 TABLET, FILM COATED in 1 BOTTLE (13107-155-01)Marketed from Dec 3, 2009
13107-155-051310701550513107015505500 TABLET, FILM COATED in 1 BOTTLE (13107-155-05)Marketed from Dec 3, 2009
13107-155-30131070155301310701553030 TABLET, FILM COATED in 1 BOTTLE (13107-155-30)Marketed from Dec 3, 2009
13107-155-90131070155901310701559090 TABLET, FILM COATED in 1 BOTTLE (13107-155-90)Marketed from Dec 3, 2009
13107-155-9913107015599131070155991000 TABLET, FILM COATED in 1 BOTTLE (13107-155-99)Marketed from Dec 3, 2009

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 — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurolife Pharma LLCNDC labeler code 13107
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 13107-155_c399d3cd-13a5-4493-9a93-c4bf5e2532fcSPL ID c399d3cd-13a5-4493-9a93-c4bf5e2532fcSPL set ID e1ea4019-bb66-403c-a3d5-6ae056a59116RxCUI 1738483, 1738495, 1738503, 1738511UNII X2ELS050D8UPC 0313107155307, 0313107154300
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

N413107015501 followed by a unit qualifier and the quantity

Package 13107-0155-01. 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)

Paroxetine tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13107-155

What is NDC 13107-155?
13107-155 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 20 mg/1 tablet, film coated, listed with the FDA by Aurolife Pharma LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Paroxetine.
What is the active ingredient?
Paroxetine hydrochloride hemihydrate.
Who is the labeler?
Aurolife Pharma LLC, NDC labeler code 13107. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Paroxetine?
145 other product NDCs are listed under this name. See all Paroxetine 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 Paroxetine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Paroxetineparoxetine hydrochloride hemihydrateParoxetine hydrochloride 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-413068788-4130-0168788-4130-0368788-4130-06+2 more
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralCoupler LLC67046-044667046-0446-03
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralCoupler LLC67046-084667046-0846-03
ParoxetineParoxetine hydrochloride hemihydrate 12.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Limited46708-76646708-0766-3046708-0766-91
ParoxetineParoxetine hydrochloride hemihydrate 12.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Inc.62332-76662332-0766-3062332-0766-91
ParoxetineParoxetine hydrochloride hemihydrate 25 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Limited46708-76746708-0767-3046708-0767-91
ParoxetineParoxetine hydrochloride hemihydrate 37.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Limited46708-76846708-0768-3046708-0768-91
ParoxetineParoxetine hydrochloride hemihydrate 25 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Inc.62332-76762332-0767-3062332-0767-91
ParoxetineParoxetine hydrochloride hemihydrate 37.5 mg/1Tablet, Film coated, Extended releaseOralAlembic Pharmaceuticals Inc.62332-76862332-0768-3062332-0768-91
Paroxetineparoxetine hydrochloride hemihydrateParoxetine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-882968788-8829-0168788-8829-0368788-8829-06+2 more

All 146 Paroxetine NDCs

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 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-713
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-156
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-154
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-157
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAvPAK50268-643
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralAvPAK50268-640
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralAvPAK50268-642
ParoxetineParoxetine hydrochloride 10 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8359
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-056
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 20 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-182
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-181
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-183
Paroxetineparoxetine hydrochlorideParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-184
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

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in