FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50228-176
11-digit product format
502280176
Labeler code
50228
Product ID
50228-176_188f0dd2-baaa-4cd2-b99e-1f86225ca7b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA205794
Marketing category
ANDA
Marketing start
2018-04-20
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
SR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
50228-176-012023-03-16C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-102023-03-16C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-302023-03-16C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-602023-03-16C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-012023-01-30C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-102023-01-30C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-302023-01-30C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-602023-01-30C16284748780-1f386c64a-092f-0266-e053-dadaa90a7c1aThese 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
50228-176-01Bupropion HydrochlorideSR100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10018
50228-176-10Bupropion HydrochlorideSR1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE100018
50228-176-30Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3018
50228-176-60Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE6018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-176-01EA - Each50228-1767f8b1a3b-5541-4398-bf66-90ac898b742412021-05-05
50228-176-60EA - Each50228-1760fdaa81d-3591-4b94-98b8-27baca648f0312020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-176BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 4 package rows20240830_092da413-ec60-4577-ac57-51e3e42d55c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN6701af43-bf7d-45c4-a331-a18d16bd68f7105
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD6701af43-bf7d-45c4-a331-a18d16bd68f7105
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY6701af43-bf7d-45c4-a331-a18d16bd68f7105
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN092da413-ec60-4577-ac57-51e3e42d55c918
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN092da413-ec60-4577-ac57-51e3e42d55c918
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN092da413-ec60-4577-ac57-51e3e42d55c918
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD092da413-ec60-4577-ac57-51e3e42d55c918
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD092da413-ec60-4577-ac57-51e3e42d55c918
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD092da413-ec60-4577-ac57-51e3e42d55c918
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY092da413-ec60-4577-ac57-51e3e42d55c918
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY092da413-ec60-4577-ac57-51e3e42d55c918
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY092da413-ec60-4577-ac57-51e3e42d55c918
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNc0445fea-108f-4e00-a2ae-ebbdf27199477
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDc0445fea-108f-4e00-a2ae-ebbdf27199477
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYc0445fea-108f-4e00-a2ae-ebbdf27199477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-176-0150228017601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-176-01) 2018-04-200000-00-00NoNoCurrent
50228-176-10502280176101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-176-10) 2018-04-200000-00-00NoNoCurrent
50228-176-305022801763030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-176-30) 2018-04-200000-00-00NoNoCurrent
50228-176-605022801766060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-176-60) 2018-04-200000-00-00NoNoCurrent