FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
53002-2509
11-digit product format
530022509
Labeler code
53002
Product ID
53002-2509_260cc5cc-1e5d-49ff-b774-f6c86886b774
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA079095
Marketing category
ANDA
Marketing start
2009-07-02
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
2021-12-31
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
53002-2509-32025-01-30C16284748780-1f386c64a-22d3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
53002-2509-62025-01-30C16284748780-1f386c64a-22d3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
53002-2509-32023-06-07C16284748780-1f386c64a-22d3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
53002-2509-62023-06-07C16284748780-1f386c64a-22d3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
53002-2509-32023-01-30C16284748780-1f386c64a-22d3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
53002-2509-62023-01-30C16284748780-1f386c64a-22d3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2509-3Bupropion HydrochlorideSR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
53002-2509-6Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2509BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 2 package rows20230609_bb082b33-f6a8-4b56-9cf1-58c5782010f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNbb082b33-f6a8-4b56-9cf1-58c5782010f16
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDbb082b33-f6a8-4b56-9cf1-58c5782010f16
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYbb082b33-f6a8-4b56-9cf1-58c5782010f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2509-35300225090330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-2509-3) 2019-01-010000-00-00NoNoCurrent
53002-2509-65300225090660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-2509-6) 2019-01-010000-00-00NoNoCurrent