Paroxetine Tablets, Usp

SPL v13

SPL

SPL Set ID 6d5fcdb2-4d84-4b20-87e3-58a43e567500

Route

ORAL

Published

Effective Date 2024-07-30

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Paroxetine (10 mg)

Inactive Ingredients

Anhydrous Dibasic Calcium Phosphate Anhydrous Lactose Hypromelloses Magnesium Stearate Polyethylene Glycol 6000 Sodium Starch Glycolate Type A Potato Povidone Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: ZC18 Shape: round Color: white Size: 6 mm Size: 8 mm Size: 10 mm Size: 11 mm Score: 1

Marketing Status

ANDA Active Since 2007-04-13

Description

NDC 65841-097-06 in pack count of 30 tablets Paroxetine Tablets USP, 10 mg R x only 30 tablets NDC 65841-098-06 in pack count of 30 tablets Paroxetine Tablets USP, 20 mg R x only 30 tablets NDC 65841-099-06 in pack count of 30 tablets Paroxetine Tablets USP, 30 mg R x only 30 tablets NDC 65841-601-06 in pack count of 30 tablets Paroxetine Tablets USP, 40 mg R x only 30 tablets

Medication Information

Description

Package Label.principal Display Panel

NDC 65841-097-06 in pack count of 30 tablets

Paroxetine Tablets USP, 10 mg

R_xonly

30 tablets

NDC 65841-098-06 in pack count of 30 tablets

Paroxetine Tablets USP, 20 mg

R_xonly

30 tablets

NDC 65841-099-06 in pack count of 30 tablets

Paroxetine Tablets USP, 30 mg

R_xonly

30 tablets

NDC 65841-601-06 in pack count of 30 tablets

Paroxetine Tablets USP, 40 mg

R_xonly

30 tablets

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-097-06 in pack count of 30 tablets

Paroxetine Tablets USP, 10 mg

R_xonly

30 tablets

NDC 65841-098-06 in pack count of 30 tablets

Paroxetine Tablets USP, 20 mg

R_xonly

30 tablets

NDC 65841-099-06 in pack count of 30 tablets

Paroxetine Tablets USP, 30 mg

R_xonly

30 tablets

NDC 65841-601-06 in pack count of 30 tablets

Paroxetine Tablets USP, 40 mg

R_xonly

30 tablets

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-097-06 in pack count of 30 tablets Paroxetine Tablets USP, 10 mg R x only 30 tablets NDC 65841-098-06 in pack count of 30 tablets Paroxetine Tablets USP, 20 mg R x only 30 tablets NDC 65841-099-06 in pack count of 30 tablets Paroxetine Tablets USP, 30 mg R x only 30 tablets NDC 65841-601-06 in pack count of 30 tablets Paroxetine Tablets USP, 40 mg R x only 30 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:44:03.747153 · Updated: 2026-03-14T22:18:33.371936