Paroxetine NDC 13107-157

Product information

Brand name (proprietary)

Paroxetine

Generic name (nonproprietary)

paroxetine

Active ingredients

Paroxetine hydrochloride hemihydrate — 40 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

Dec 3, 2009

Listing expires

Dec 31, 2027

Other FDA classes

Serotonin Uptake Inhibitors (Mechanism)

Identifiers

Product ID 13107-157_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

N413107015701 followed by a unit qualifier and the quantity Copy

Package 13107-0157-01. 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 13107-157

What is NDC 13107-157?

13107-157 is the product NDC for Paroxetine, Paroxetine hydrochloride hemihydrate 40 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.

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.