FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-1114
11-digit product format
713351114
Labeler code
71335
Product ID
71335-1114_99d9c657-4add-4f6e-8c5d-75d888473e23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210081
Marketing category
ANDA
Marketing start
2018-08-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
(XL)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

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
71335-1114-12024-05-17C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-22024-05-17C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-32024-05-17C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-42024-05-17C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-52024-05-17C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-12024-01-30C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-22024-01-30C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-32024-01-30C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-42024-01-30C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985
71335-1114-52024-01-30C16284748780-11030e365-0e58-111a-e063-dadaa90a10e2These 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 USP (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1114-1Bupropion Hydrochloride(XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE304
71335-1114-2Bupropion Hydrochloride(XL)60 in 1 BOTTLETABLET, EXTENDED RELEASE604
71335-1114-3Bupropion Hydrochloride(XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE904
71335-1114-4Bupropion Hydrochloride(XL)120 in 1 BOTTLETABLET, EXTENDED RELEASE1204
71335-1114-5Bupropion Hydrochloride(XL)8 in 1 BOTTLETABLET, EXTENDED RELEASE84
71335-1114-6Bupropion Hydrochloride(XL)180 in 1 BOTTLETABLET, EXTENDED RELEASE1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1114-3EA - Each71335-1114f4eeafc8-886e-4c89-92ef-140855a8be8e12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1114BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 6 package rows20240913_64be3113-837a-48f3-9f9e-400529c9ee94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN64be3113-837a-48f3-9f9e-400529c9ee944
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD64be3113-837a-48f3-9f9e-400529c9ee944
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY64be3113-837a-48f3-9f9e-400529c9ee944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1114-17133511140130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1114-1) 2019-02-220000-00-00NoNoCurrent
71335-1114-27133511140260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1114-2) 2024-09-050000-00-00NoNoCurrent
71335-1114-37133511140390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1114-3) 2019-02-210000-00-00NoNoCurrent
71335-1114-471335111404120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1114-4) 2019-03-290000-00-00NoNoCurrent
71335-1114-5713351114058 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1114-5) 2024-09-050000-00-00NoNoCurrent
71335-1114-671335111406180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1114-6) 2024-09-05NoNoHistorical