FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
24979-102
11-digit product format
249790102
Labeler code
24979
Product ID
24979-102_48f10028-3408-4db8-95e5-00e19f0152c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA210081
Marketing category
ANDA
Marketing start
2018-08-30
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
(XL)

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
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
24979-102-02Bupropion Hydrochloride(XL)500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE50013
24979-102-06Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3013
24979-102-07Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-102-02EA - Each24979-102fcc28a3f-ef8e-4eb9-8180-355a35634b3212018-10-11
24979-102-06EA - Each24979-102de910878-2e4b-43b6-b1f9-44a5093b9cbb12018-10-11
24979-102-07EA - Each24979-1026cba4c71-26c4-4b84-b0f8-05724d3b1bc912018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-102BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 3 package rows20241006_cdf6e6d9-28e4-48a8-a5ae-7549b3e1402a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN9d5360f5-f747-4baf-8e6c-ddca1a9c871a102
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD9d5360f5-f747-4baf-8e6c-ddca1a9c871a102
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY9d5360f5-f747-4baf-8e6c-ddca1a9c871a102
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNd017f3dc-3688-487f-9130-808b33976b2216
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDd017f3dc-3688-487f-9130-808b33976b2216
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYd017f3dc-3688-487f-9130-808b33976b2216
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNcdf6e6d9-28e4-48a8-a5ae-7549b3e1402a13
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNcdf6e6d9-28e4-48a8-a5ae-7549b3e1402a13
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDcdf6e6d9-28e4-48a8-a5ae-7549b3e1402a13
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDcdf6e6d9-28e4-48a8-a5ae-7549b3e1402a13
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYcdf6e6d9-28e4-48a8-a5ae-7549b3e1402a13
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYcdf6e6d9-28e4-48a8-a5ae-7549b3e1402a13
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN64be3113-837a-48f3-9f9e-400529c9ee944
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD64be3113-837a-48f3-9f9e-400529c9ee944
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY64be3113-837a-48f3-9f9e-400529c9ee944
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN2af578d8-a7f8-4da3-b126-390a0e950fad2
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN2af578d8-a7f8-4da3-b126-390a0e950fad2
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD2af578d8-a7f8-4da3-b126-390a0e950fad2
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD2af578d8-a7f8-4da3-b126-390a0e950fad2
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY2af578d8-a7f8-4da3-b126-390a0e950fad2
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY2af578d8-a7f8-4da3-b126-390a0e950fad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-102-0224979010202500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-102-02) 2018-08-302026-06-30NoNoCurrent
24979-102-062497901020630 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-102-06) 2018-08-302026-06-30NoNoCurrent
24979-102-072497901020790 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-102-07) 2018-08-302026-06-30NoNoCurrent