FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-0135
11-digit product format
713350135
Labeler code
71335
Product ID
71335-0135_bd3430d7-bb57-4d5d-89f8-4b0c76169ebb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079095
Marketing category
ANDA
Marketing start
2009-07-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
SR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993518

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
71335-0135-12024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-22024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-32024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-42024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-52024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-62024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-72024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-82024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-92024-05-17C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-12024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-22024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-32024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-42024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-52024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-62024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-72024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-82024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-92024-01-30C16284748780-11030e365-27f9-111a-e063-dadaa90a10e2These 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
71335-0135-1Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6011
71335-0135-2Bupropion HydrochlorideSR90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9011
71335-0135-3Bupropion HydrochlorideSR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3011
71335-0135-4Bupropion HydrochlorideSR120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE12011
71335-0135-5Bupropion HydrochlorideSR45 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE4511
71335-0135-6Bupropion HydrochlorideSR180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE18011
71335-0135-7Bupropion HydrochlorideSR28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2811
71335-0135-8Bupropion HydrochlorideSR56 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5611
71335-0135-9Bupropion HydrochlorideSR100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0135-1EA - Each71335-0135a88040b3-7918-4f3a-988b-8b061b15512c12018-03-08
71335-0135-2EA - Each71335-0135f403d74c-d97a-49b4-abde-938ba189d8c812018-03-08
71335-0135-3EA - Each71335-01356da324f5-d6a8-4cc1-b0dd-8c1f5fded46912018-03-08
71335-0135-4EA - Each71335-0135065d53fd-8f88-4275-ab98-47c21ccf2a7012018-03-08
71335-0135-5EA - Each71335-01356fdb8c54-c515-4a01-b7e7-e1019266c58512018-03-08
71335-0135-6EA - Each71335-01354625a40c-e035-4834-bd10-120586f07ac512018-03-08
71335-0135-7EA - Each71335-0135d89b6d8f-bd7e-4016-bbc7-43deb75bd3d112018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0135BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 9 package rows20241025_ec8c699f-a8de-4e5a-a223-8de3f5dfe20d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNec8c699f-a8de-4e5a-a223-8de3f5dfe20d11
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDec8c699f-a8de-4e5a-a223-8de3f5dfe20d11
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYec8c699f-a8de-4e5a-a223-8de3f5dfe20d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0135-17133501350160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-1) 2019-09-110000-00-00NoNoCurrent
71335-0135-27133501350290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-2) 2019-09-180000-00-00NoNoCurrent
71335-0135-37133501350330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-3) 2019-09-110000-00-00NoNoCurrent
71335-0135-471335013504120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-4) 2024-10-080000-00-00NoNoCurrent
71335-0135-57133501350545 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-5) 2024-10-080000-00-00NoNoCurrent
71335-0135-671335013506180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-6) 2024-10-080000-00-00NoNoCurrent
71335-0135-77133501350728 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-7) 2024-10-080000-00-00NoNoCurrent
71335-0135-87133501350856 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-8) 2024-10-080000-00-00NoNoCurrent
71335-0135-971335013509100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0135-9) 2024-10-080000-00-00NoNoCurrent