FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50228-144
11-digit product format
502280144
Labeler code
50228
Product ID
50228-144_1105c206-a0be-4ea0-a6e3-1371ac2df153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals,Inc.
Application
ANDA207479
Marketing category
ANDA
Marketing start
2017-04-12
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
(XL)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-144-05Bupropion Hydrochloride(XL)500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50011
50228-144-30Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3011
50228-144-90Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-144-05EA - Each50228-1441ad3005f-eab4-4d4f-8c57-aaf6f43915c612020-07-13
50228-144-30EA - Each50228-144bd4254d6-6f5b-4361-93d3-52788ec79b0412020-07-13
50228-144-90EA - Each50228-1441b6442d0-408c-4b3e-a864-95006aabed4412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-144BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS,INC.]8Current NDC, Legacy NDC, 3 package rows20220409_05f82eca-cc87-4580-acd7-e6491c651881.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNcefaaa17-f79a-4ba6-8f97-a59f60e07b75105
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDcefaaa17-f79a-4ba6-8f97-a59f60e07b75105
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYcefaaa17-f79a-4ba6-8f97-a59f60e07b75105
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN03b1b0a9-0aa2-4039-acce-68ca54abaae4104
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD03b1b0a9-0aa2-4039-acce-68ca54abaae4104
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY03b1b0a9-0aa2-4039-acce-68ca54abaae4104
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN05f82eca-cc87-4580-acd7-e6491c65188111
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN05f82eca-cc87-4580-acd7-e6491c65188111
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD05f82eca-cc87-4580-acd7-e6491c65188111
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD05f82eca-cc87-4580-acd7-e6491c65188111
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY05f82eca-cc87-4580-acd7-e6491c65188111
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY05f82eca-cc87-4580-acd7-e6491c65188111
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c46
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c46
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c46
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN57a9f4d3-0c41-4978-b81e-cf3059bc8c424
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD57a9f4d3-0c41-4978-b81e-cf3059bc8c424
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY57a9f4d3-0c41-4978-b81e-cf3059bc8c424
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN4ddf6ba2-c020-7912-e063-6394a90a79641
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD4ddf6ba2-c020-7912-e063-6394a90a79641
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY4ddf6ba2-c020-7912-e063-6394a90a79641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-144-0550228014405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-144-05) 2017-04-120000-00-00NoNoCurrent
50228-144-305022801443030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-144-30) 2017-04-120000-00-00NoNoCurrent
50228-144-905022801449090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-144-90) 2017-04-120000-00-00NoNoCurrent