FDA.reportPublic FDA data

buPropion Hydrochloride

Product NDC
71765-002
11-digit product format
717650002
Labeler code
71765
Product ID
71765-002_98bf4e22-8ea2-9303-e053-2a95a90ad434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zhejiang Jutai Pharamceutical Co., Ltd
Application
ANDA211200
Marketing category
ANDA
Marketing start
2020-12-06
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
2020-12-31
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
71765-002-032021-01-29C16284748780-1ba0f9c33-4965-a910-e053-dadaa90a0b85These 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
71765-002-092021-01-29C16284748780-1ba0f9c33-4965-a910-e053-dadaa90a0b85These 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
71765-002-502021-01-29C16284748780-1ba0f9c33-4965-a910-e053-dadaa90a0b85These 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
71765-002-03buPropion HydrochlorideXL30 in 1 BOTTLETABLET, EXTENDED RELEASE309
71765-002-09buPropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE909
71765-002-50buPropion HydrochlorideXL500 in 1 BOTTLETABLET, EXTENDED RELEASE5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71765-002BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ZHEJIANG JUTAI PHARAMCEUTICAL CO., LTD]9Legacy NDC, 3 package rows20201206_1f25201c-1a15-4da1-a250-e91040df8774.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN1f25201c-1a15-4da1-a250-e91040df87749
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD1f25201c-1a15-4da1-a250-e91040df87749
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY1f25201c-1a15-4da1-a250-e91040df87749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71765-002-037176500020330 in 1 BOTTLEHistorical
71765-002-097176500020990 in 1 BOTTLEHistorical
71765-002-5071765000250500 in 1 BOTTLEHistorical