NDC codes

FDA NDC Directory
Product NDC (as listed)62135-542Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0542Add 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
62135-542-90621350542906213505429090 TABLET, FILM COATED in 1 BOTTLE (62135-542-90)Marketed from Apr 11, 2023

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
Chartwell RX, LLC.NDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211248
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 62135-542_4687b126-663e-b64a-e063-6294a90affa1SPL ID 4687b126-663e-b64a-e063-6294a90affa1SPL set ID 69699d40-4a64-4337-8664-e4e093437fbfRxCUI 1738483, 1738495, 1738503, 1738511UNII X2ELS050D8UPC 0362135544904, 0362135542900, 0362135541903, 0362135543907
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

N462135054290 followed by a unit qualifier and the quantity

Package 62135-0542-90. 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 is 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 62135-542

What is NDC 62135-542?
62135-542 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 20 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC.. It has 1 package NDC, 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?
Chartwell RX, LLC., NDC labeler code 62135. 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 211248

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

FDA NDC Directory listings under ANDA 211248
ProductStrengthForm · routeLabelerProduct NDC
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralChartwell RX, LLC.62135-541
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralChartwell RX, LLC.62135-543
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralChartwell RX, LLC.62135-544
ParoxetineParoxetine hydrochloride hemihydrate 10 mg/1Tablet, Film coatedOralYiling Pharmaceutical, Inc.69117-0024
ParoxetineParoxetine hydrochloride hemihydrate 20 mg/1Tablet, Film coatedOralYiling Pharmaceutical, Inc.69117-0025
ParoxetineParoxetine hydrochloride hemihydrate 30 mg/1Tablet, Film coatedOralYiling Pharmaceutical, Inc.69117-0026
ParoxetineParoxetine hydrochloride hemihydrate 40 mg/1Tablet, Film coatedOralYiling Pharmaceutical, Inc.69117-0027

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