FDA.reportPublic FDA data

Bupropion Hydrochloride Extended Release

Product NDC
10135-704
11-digit product format
101350704
Labeler code
10135
Product ID
10135-704_c9b12a1f-3e31-0811-e053-2995a90a4d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA211200
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
2022-12-31
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
10135-704-052023-01-30C16284748780-1f386c649-fa9b-0266-e053-dadaa90a7c1aThese 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-REL EASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-rel ease tablets (XL), for oral use Initial U.S. Approval: 1985
10135-704-302023-01-30C16284748780-1f386c649-fa9b-0266-e053-dadaa90a7c1aThese 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-REL EASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-rel ease tablets (XL), for oral use Initial U.S. Approval: 1985
10135-704-902023-01-30C16284748780-1f386c649-fa9b-0266-e053-dadaa90a7c1aThese 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-REL EASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-rel ease tablets (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-704-05Bupropion Hydrochloride Extended Release500 in 1 BOTTLETABLET5005
10135-704-30Bupropion Hydrochloride Extended Release30 in 1 BOTTLETABLET305
10135-704-90Bupropion Hydrochloride Extended Release90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-704-05EA - Each10135-704a8fb0323-5ba7-4fbb-8f4c-0416ce55412912021-04-08
10135-704-30EA - Each10135-7048ef627e8-b3f2-4cc3-a7de-5191b1b5ddbe12021-04-08
10135-704-90EA - Each10135-7040ea84687-0517-4dee-b155-ac8621a7aebb12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-704BUPROPION HYDROCHLORIDE EXTENDED RELEASE (BUPROPION HYDROCHLORIDE) TABLET [MARLEX PHARMACEUTICALS INC]5Legacy NDC, 3 package rows20210819_cf69c6c4-d2d8-4a41-aff8-a67abd3a037e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYcf69c6c4-d2d8-4a41-aff8-a67abd3a037e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-704-0510135070405500 TABLET in 1 BOTTLE (10135-704-05) 500 tablet2020-07-010000-00-00NoNoCurrent
10135-704-301013507043030 TABLET in 1 BOTTLE (10135-704-30) 30 tablet2020-07-010000-00-00NoNoCurrent
10135-704-901013507049090 TABLET in 1 BOTTLE (10135-704-90) 90 tablet2020-07-010000-00-00NoNoCurrent