Bupropion Hydrochloride Extended-release Tablets (xl)

SPL v11

SPL

SPL Set ID 78d34aad-9d4f-48c4-91eb-536e31c6b6c9

Route

ORAL

Published

Effective Date 2023-09-20

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bupropion (300 mg)

Inactive Ingredients

Hypromelloses Magnesium Stearate Methacrylic Acid Polyethylene Glycol, Unspecified Triethyl Citrate Povidone Ethylcelluloses Silicon Dioxide Butyl Alcohol Ferrosoferric Oxide Isopropyl Alcohol Propylene Glycol Shellac Ammonia

Identifiers & Packaging

Pill Appearance

Imprint: 353 Shape: round Color: yellow Size: 9 mm Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2018-08-02

Description

Manufactured by: Cadila Healthcare Ltd. India.

Medication Information

Description

Manufactured by: Cadila Healthcare Ltd. India.

Section 42231-1

Manufactured by:

Cadila Healthcare Ltd.

India.

Package Label.principal Display Panel

NDC 65841-780-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg

500 Tablets

Rx only

NDC 65841-836-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg

500 Tablets

Rx only

Structured Label Content

Section 42231-1 (42231-1)

Manufactured by:

Cadila Healthcare Ltd.

India.

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

NDC 65841-780-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg

500 Tablets

Rx only

NDC 65841-836-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg

500 Tablets

Rx only

Advanced Ingredient Data

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"classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSES", "unii": "7Z8S9VYZ4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL ALCOHOL", "unii": "8PJ61P6TS3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUPROPION", "unii": "01ZG3TPX31", "classCode": "ACTIB", "strengthNumerator": "150", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID", "unii": "1CS02G8656", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHYL CITRATE", "unii": "8Z96QXD6UM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSES", "unii": "7Z8S9VYZ4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL ALCOHOL", "unii": "8PJ61P6TS3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42231-1": "Manufactured by: Cadila Healthcare Ltd. India.", "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-780-05 Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg 500 Tablets Rx only NDC 65841-836-05 Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg 500 Tablets Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:57.688223 · Updated: 2026-03-14T22:18:11.806691