FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50228-174
11-digit product format
502280174
Labeler code
50228
Product ID
50228-174_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
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
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 HYDROCHLORIDE100 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
50228-174-012023-03-16C16284748780-1f386c64a-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
50228-174-052023-03-16C16284748780-1f386c64a-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
50228-174-102023-03-16C16284748780-1f386c64a-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
50228-174-302023-03-16C16284748780-1f386c64a-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
50228-174-602023-03-16C16284748780-1f386c64a-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
50228-174-012023-01-30C16284748780-1f386c64a-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
50228-174-052023-01-30C16284748780-1f386c64a-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
50228-174-102023-01-30C16284748780-1f386c64a-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
50228-174-302023-01-30C16284748780-1f386c64a-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
50228-174-602023-01-30C16284748780-1f386c64a-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
50228-174-01Bupropion HydrochlorideSR100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10018
50228-174-05Bupropion HydrochlorideSR500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50018
50228-174-10Bupropion HydrochlorideSR1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE100018
50228-174-30Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3018
50228-174-60Bupropion 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
50228-174-01EA - Each50228-17498349700-afc8-494c-be6c-dc4590df64b912020-05-08
50228-174-05EA - Each50228-174c0116ffc-3ca2-41a7-863b-f76a52507b4c12020-05-08
50228-174-60EA - Each50228-174d1746c46-e14d-4481-9313-d7ed03a7680412020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-174BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 5 package rows20240830_092da413-ec60-4577-ac57-51e3e42d55c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN21be6b3b-add3-43e7-af93-30350aefc89e105
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD21be6b3b-add3-43e7-af93-30350aefc89e105
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY21be6b3b-add3-43e7-af93-30350aefc89e105
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN9d0608a1-0cc8-491a-ad91-238e0ea009fe18
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 TabletSCD9d0608a1-0cc8-491a-ad91-238e0ea009fe18
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
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY9d0608a1-0cc8-491a-ad91-238e0ea009fe18
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
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNd1d1ed19-e111-4652-a0d4-9406e6f73e9f7
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDd1d1ed19-e111-4652-a0d4-9406e6f73e9f7
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYd1d1ed19-e111-4652-a0d4-9406e6f73e9f7
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNc76f2f9f-3999-4bdd-8ec3-e0066318d3786
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDc76f2f9f-3999-4bdd-8ec3-e0066318d3786
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYc76f2f9f-3999-4bdd-8ec3-e0066318d3786
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNd1f0b71f-ad23-1cb3-e053-2995a90acfe61
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN6dc4a55b-c0c0-4cbe-988e-da81f0c4f75e1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD6dc4a55b-c0c0-4cbe-988e-da81f0c4f75e1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDd1f0b71f-ad23-1cb3-e053-2995a90acfe61
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY6dc4a55b-c0c0-4cbe-988e-da81f0c4f75e1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYd1f0b71f-ad23-1cb3-e053-2995a90acfe61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-174-0150228017401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-01) 2018-04-200000-00-00NoNoCurrent
50228-174-0550228017405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-05) 2018-04-200000-00-00NoNoCurrent
50228-174-10502280174101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-10) 2018-04-200000-00-00NoNoCurrent
50228-174-305022801743030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-30) 2018-04-200000-00-00NoNoCurrent
50228-174-605022801746060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-174-60) 2018-04-200000-00-00NoNoCurrent