Paroxetine (Paroxetine hydrochloride) NDC 65862-157

Product information

Brand name (proprietary)

Paroxetine

Generic name (nonproprietary)

paroxetine hydrochloride

Active ingredients

Paroxetine hydrochloride hemihydrate — 40 mg/1

Dosage form

Tablet, Film coated

Route

Oral

Labeler

Aurobindo Pharma LimitedNDC labeler code 65862

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 078406

Marketing start

Jul 25, 2007

Listing expires

Dec 31, 2027

Other FDA classes

Serotonin Uptake Inhibitors (Mechanism)

Identifiers

Product ID 65862-157_19f7a08f-58bd-45b8-a750-4432ae161455SPL ID 19f7a08f-58bd-45b8-a750-4432ae161455SPL set ID 326e8ab0-6886-4749-9544-885b37070051RxCUI 1738483, 1738495, 1738503, 1738511UNII X2ELS050D8UPC 0365862154019

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

N465862015701 followed by a unit qualifier and the quantity Copy

Package 65862-0157-01. 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

About NDC 65862-157

What is NDC 65862-157?

65862-157 is the product NDC for Paroxetine (paroxetine hydrochloride), Paroxetine hydrochloride hemihydrate 40 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Paroxetine (Paroxetine Hydrochloride).

What is the active ingredient?

Paroxetine hydrochloride hemihydrate.

Who is the labeler?

Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Related NDCs: other Paroxetine products

Other finished products listed under the same name: strengths, forms and labelers.

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.