FDA.reportPublic FDA data

Bupropion HydrochlorideXL

Product NDC
53217-279
11-digit product format
532170279
Labeler code
53217
Product ID
53217-279_ae5cc052-7891-40e0-921e-ca706fc4877a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-11-26
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-279-142020-01-31C16284748780-19d75b9d0-817c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
53217-279-302020-01-31C16284748780-19d75b9d0-817c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
53217-279-602020-01-31C16284748780-19d75b9d0-817c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
53217-279-902020-01-31C16284748780-19d75b9d0-817c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
53217-279-992020-01-31C16284748780-19d75b9d0-817c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-279-14Bupropion HydrochlorideXLXL14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE141
53217-279-30Bupropion HydrochlorideXLXL30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
53217-279-60Bupropion HydrochlorideXLXL60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
53217-279-90Bupropion HydrochlorideXLXL90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
53217-279-99Bupropion HydrochlorideXLXL180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-279-14EA - Each53217-279ccdf1c86-b2fb-4fa4-acca-e18f9a2c44ba12017-04-05
53217-279-30EA - Each53217-27971924880-2130-4f85-9876-917889707c5d12017-04-05
53217-279-60EA - Each53217-27915edbbb8-e585-4096-a81e-d73cb5ecd0ea12017-04-05
53217-279-90EA - Each53217-279aee7c1ee-d895-4467-bf3a-796a76c0809312017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-279BUPROPION HYDROCHLORIDEXL XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 5 package rows20170310_af94e1a9-fb47-4842-8cde-5b5f44fb83cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-279-145321702791414 in 1 BOTTLEHistorical
53217-279-305321702793030 in 1 BOTTLEHistorical
53217-279-605321702796060 in 1 BOTTLEHistorical
53217-279-905321702799090 in 1 BOTTLEHistorical
53217-279-9953217027999180 in 1 BOTTLEHistorical