Paroxetine (Paroxetine hydrochloride hemihydrate) NDC 68788-8829

Product information

Brand name (proprietary)

Paroxetine

Generic name (nonproprietary)

paroxetine hydrochloride hemihydrate

Active ingredients

Paroxetine hydrochloride — 10 mg/1

Dosage form

Tablet, Film coated

Route

Oral

Labeler

Preferred Pharmaceuticals Inc.NDC labeler code 68788

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 203854

Marketing start

Feb 13, 2025

Listing expires

Dec 31, 2026

Other FDA classes

Serotonin Uptake Inhibitors (Mechanism)

Identifiers

Product ID 68788-8829_91c5a321-e174-4d86-9a84-e5e278d45affSPL ID 91c5a321-e174-4d86-9a84-e5e278d45affSPL set ID 91c5a321-e174-4d86-9a84-e5e278d45affRxCUI 1738483UNII 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

N468788882901 followed by a unit qualifier and the quantity Copy

Package 68788-8829-01. 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 68788-8829

What is NDC 68788-8829?

68788-8829 is the product NDC for Paroxetine (paroxetine hydrochloride hemihydrate), Paroxetine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Paroxetine (Paroxetine hydrochloride hemihydrate).

What is the active ingredient?

Paroxetine hydrochloride.

Who is the labeler?

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 203854

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

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