FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50228-145
11-digit product format
502280145
Labeler code
50228
Product ID
50228-145_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
300 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 HYDROCHLORIDE300 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
50228-145-05Bupropion Hydrochloride(XL)500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50011
50228-145-30Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3011
50228-145-90Bupropion 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
50228-145-05EA - Each50228-145b7c20074-81e3-471c-a4e7-a38d445b21e512020-07-13
50228-145-30EA - Each50228-145e040c74a-4b8e-4a09-b3c5-099a0b3d4ab012020-07-13
50228-145-90EA - Each50228-145289b79a9-f8b3-4203-8977-415798392a9e12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-145BUPROPION 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
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN96e78f74-fad0-4ae1-9e68-55e4c6ab2d60105
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD96e78f74-fad0-4ae1-9e68-55e4c6ab2d60105
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY96e78f74-fad0-4ae1-9e68-55e4c6ab2d60105
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa5417808-f767-48fc-9f5d-c1aeee4e57c3104
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa5417808-f767-48fc-9f5d-c1aeee4e57c3104
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa5417808-f767-48fc-9f5d-c1aeee4e57c3104
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN8499470a-8d01-4348-b67b-8f49728031cb102
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD8499470a-8d01-4348-b67b-8f49728031cb102
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY8499470a-8d01-4348-b67b-8f49728031cb102
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa7553281-be90-47e3-8d2b-b027f6d18d3a101
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa7553281-be90-47e3-8d2b-b027f6d18d3a101
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa7553281-be90-47e3-8d2b-b027f6d18d3a101
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
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN4cc3327b-92c5-4667-ae16-3e95eafcf4d86
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD4cc3327b-92c5-4667-ae16-3e95eafcf4d86
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY4cc3327b-92c5-4667-ae16-3e95eafcf4d86
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN3d826804-6427-aae1-e063-6394a90a65931
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN0ac739de-ad59-4882-810e-f52db22ac96f1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNd6efb695-c439-48d7-a155-5c661a5049af1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD3d826804-6427-aae1-e063-6394a90a65931
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD0ac739de-ad59-4882-810e-f52db22ac96f1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDd6efb695-c439-48d7-a155-5c661a5049af1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY3d826804-6427-aae1-e063-6394a90a65931
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY0ac739de-ad59-4882-810e-f52db22ac96f1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYd6efb695-c439-48d7-a155-5c661a5049af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-145-0550228014505500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-05) 2017-04-120000-00-00NoNoCurrent
50228-145-305022801453030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-30) 2017-04-120000-00-00NoNoCurrent
50228-145-905022801459090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-90) 2017-04-120000-00-00NoNoCurrent