FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-1986
11-digit product format
713351986
Labeler code
71335
Product ID
71335-1986_81a9f421-c489-4306-a693-94e61aa30b39
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
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
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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503

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
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
71335-1986-1Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, EXTENDED RELEASE60105
71335-1986-2Bupropion HydrochlorideSR90 in 1 BOTTLETABLET, EXTENDED RELEASE90105
71335-1986-3Bupropion HydrochlorideSR30 in 1 BOTTLETABLET, EXTENDED RELEASE30105
71335-1986-4Bupropion HydrochlorideSR45 in 1 BOTTLETABLET, EXTENDED RELEASE45105
71335-1986-5Bupropion HydrochlorideSR28 in 1 BOTTLETABLET, EXTENDED RELEASE28105
71335-1986-6Bupropion HydrochlorideSR120 in 1 BOTTLETABLET, EXTENDED RELEASE120105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1986BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 6 package rows20240726_500fc18d-93b4-47d5-a3f7-3f68822d83e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN500fc18d-93b4-47d5-a3f7-3f68822d83e8105
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD500fc18d-93b4-47d5-a3f7-3f68822d83e8105
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY500fc18d-93b4-47d5-a3f7-3f68822d83e8105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1986-17133519860160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1986-1) 2021-11-040000-00-00NoNoCurrent
71335-1986-27133519860290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1986-2) 2024-07-180000-00-00NoNoCurrent
71335-1986-37133519860330 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1986-3) 2024-07-180000-00-00NoNoCurrent
71335-1986-47133519860445 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1986-4) 2024-07-180000-00-00NoNoCurrent
71335-1986-57133519860528 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1986-5) 2024-07-180000-00-00NoNoCurrent
71335-1986-671335198606120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1986-6) 2022-12-290000-00-00NoNoCurrent