FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50228-175
11-digit product format
502280175
Labeler code
50228
Product ID
50228-175_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
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
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 HYDROCHLORIDE150 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
50228-175-012023-03-16C16284748780-1f386c64a-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
50228-175-052023-03-16C16284748780-1f386c64a-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
50228-175-102023-03-16C16284748780-1f386c64a-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
50228-175-302023-03-16C16284748780-1f386c64a-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
50228-175-602023-03-16C16284748780-1f386c64a-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
50228-175-012023-01-30C16284748780-1f386c64a-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
50228-175-052023-01-30C16284748780-1f386c64a-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
50228-175-102023-01-30C16284748780-1f386c64a-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
50228-175-302023-01-30C16284748780-1f386c64a-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
50228-175-602023-01-30C16284748780-1f386c64a-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
50228-175-01Bupropion HydrochlorideSR100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10018
50228-175-05Bupropion HydrochlorideSR500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50018
50228-175-10Bupropion HydrochlorideSR1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE100018
50228-175-30Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3018
50228-175-60Bupropion 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
50228-175-01EA - Each50228-17530a07938-fe24-4ef3-b31a-17751b881ff712020-05-08
50228-175-05EA - Each50228-175861ce7fa-9e38-49aa-9639-f0f669822eb312020-05-08
50228-175-60EA - Each50228-175d4a92df8-0b36-46e6-bf57-ccda82ca645112020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-175BUPROPION 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
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNa72db723-df4b-4bf4-9bdc-05ae82058696108
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDa72db723-df4b-4bf4-9bdc-05ae82058696108
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYa72db723-df4b-4bf4-9bdc-05ae82058696108
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNc37bb183-f272-4cae-96e1-7042c1dd7bcf105
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDc37bb183-f272-4cae-96e1-7042c1dd7bcf105
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYc37bb183-f272-4cae-96e1-7042c1dd7bcf105
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNfd153957-ff74-4134-8545-cdc0e5619906104
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDfd153957-ff74-4134-8545-cdc0e5619906104
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYfd153957-ff74-4134-8545-cdc0e5619906104
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
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa8
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa8
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa8
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNb47c5515-a438-40bc-b8ad-26a6cf9676b77
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDb47c5515-a438-40bc-b8ad-26a6cf9676b77
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYb47c5515-a438-40bc-b8ad-26a6cf9676b77
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN0865f8cf-1d7f-0e67-e063-6294a90a2f4d6
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0865f8cf-1d7f-0e67-e063-6294a90a2f4d6
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY0865f8cf-1d7f-0e67-e063-6294a90a2f4d6
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN73167de9-948d-465c-88c0-c7743a79e7f54
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNdd4041cd-00e4-d10f-e053-2a95a90a59454
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN339c7157-1c65-40d1-bbcc-c10348d908d34
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDdd4041cd-00e4-d10f-e053-2a95a90a59454
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD73167de9-948d-465c-88c0-c7743a79e7f54
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD339c7157-1c65-40d1-bbcc-c10348d908d34
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY339c7157-1c65-40d1-bbcc-c10348d908d34
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYdd4041cd-00e4-d10f-e053-2a95a90a59454
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY73167de9-948d-465c-88c0-c7743a79e7f54
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNb1169882-c785-62ab-e053-2995a90ae6413
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN1094ff8e-f5a5-4a72-8bf9-25e68f5c964a3
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNeeb3fed1-2202-09fc-e053-2995a90a9f633
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDb1169882-c785-62ab-e053-2995a90ae6413
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1094ff8e-f5a5-4a72-8bf9-25e68f5c964a3
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDeeb3fed1-2202-09fc-e053-2995a90a9f633
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY1094ff8e-f5a5-4a72-8bf9-25e68f5c964a3
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYb1169882-c785-62ab-e053-2995a90ae6413
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYeeb3fed1-2202-09fc-e053-2995a90a9f633
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN4bd469b8-fb35-0223-e063-6294a90ae7bc1
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNea3c460f-521e-7da9-e053-2a95a90a37ca1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD4bd469b8-fb35-0223-e063-6294a90ae7bc1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDea3c460f-521e-7da9-e053-2a95a90a37ca1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYea3c460f-521e-7da9-e053-2a95a90a37ca1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY4bd469b8-fb35-0223-e063-6294a90ae7bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-175-0150228017501100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-01) 2018-04-200000-00-00NoNoCurrent
50228-175-0550228017505500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-05) 2018-04-200000-00-00NoNoCurrent
50228-175-10502280175101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-10) 2018-04-200000-00-00NoNoCurrent
50228-175-305022801753030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-30) 2018-04-200000-00-00NoNoCurrent
50228-175-605022801756060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-60) 2018-04-200000-00-00NoNoCurrent