FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-1837
11-digit product format
713351837
Labeler code
71335
Product ID
71335-1837_baf029ae-b819-465b-82e9-82167b132b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211347
Marketing category
ANDA
Marketing start
2020-11-02
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1837-1Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, EXTENDED RELEASE60106
71335-1837-2Bupropion HydrochlorideSR90 in 1 BOTTLETABLET, EXTENDED RELEASE90106
71335-1837-3Bupropion HydrochlorideSR30 in 1 BOTTLETABLET, EXTENDED RELEASE30106
71335-1837-4Bupropion HydrochlorideSR120 in 1 BOTTLETABLET, EXTENDED RELEASE120106
71335-1837-5Bupropion HydrochlorideSR45 in 1 BOTTLETABLET, EXTENDED RELEASE45106
71335-1837-6Bupropion HydrochlorideSR180 in 1 BOTTLETABLET, EXTENDED RELEASE180106
71335-1837-7Bupropion HydrochlorideSR28 in 1 BOTTLETABLET, EXTENDED RELEASE28106
71335-1837-8Bupropion HydrochlorideSR56 in 1 BOTTLETABLET, EXTENDED RELEASE56106
71335-1837-9Bupropion HydrochlorideSR100 in 1 BOTTLETABLET, EXTENDED RELEASE100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1837-1EA - Each71335-183735f6041d-ff9d-48bc-9040-515a8f40a47212022-03-09
71335-1837-3EA - Each71335-183784d5806e-0ebd-45d1-9735-171eb0385ce312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1837BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 9 package rows20240726_0574b84d-075f-410f-a8eb-86901e307ea2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN0574b84d-075f-410f-a8eb-86901e307ea2106
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0574b84d-075f-410f-a8eb-86901e307ea2106
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY0574b84d-075f-410f-a8eb-86901e307ea2106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1837-17133518370160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-1) 2021-05-050000-00-00NoNoCurrent
71335-1837-27133518370290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-2) 2022-02-170000-00-00NoNoCurrent
71335-1837-37133518370330 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-3) 2021-04-260000-00-00NoNoCurrent
71335-1837-471335183704120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-4) 2024-07-170000-00-00NoNoCurrent
71335-1837-57133518370545 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-5) 2024-07-170000-00-00NoNoCurrent
71335-1837-671335183706180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-6) 2022-02-020000-00-00NoNoCurrent
71335-1837-77133518370728 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-7) 2024-07-170000-00-00NoNoCurrent
71335-1837-87133518370856 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-8) 2024-07-170000-00-00NoNoCurrent
71335-1837-971335183709100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1837-9) 2024-07-170000-00-00NoNoCurrent