FDA.reportPublic FDA data

WELLBUTRIN XL

Product NDC
21695-138
11-digit product format
216950138
Labeler code
21695
Product ID
21695-138_fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021515
Marketing category
NDA
Marketing start
2009-12-23
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-138-152019-09-24C16284748780-1934fe258-4755-48b1-e053-8cdaa90a720aWELLBUTRIN XL ® (bupropion hydrochloride extended-release tablets)
21695-138-302019-09-24C16284748780-1934fe258-4755-48b1-e053-8cdaa90a720aWELLBUTRIN XL ® (bupropion hydrochloride extended-release tablets)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-138-15WELLBUTRIN XL15 in 1 BOTTLETABLET, EXTENDED RELEASE151
21695-138-30WELLBUTRIN XL30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-138-15EA - Each21695-13874db5c85-6965-4e63-be53-05d8ab67f04212012-07-24
21695-138-30EA - Each21695-13851c1e6d7-4f85-46dc-b9e2-c242259f93b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bupropion hydrochlorideACTIVE INGREDIENTZG7E5POY8OWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
bupropionACTIVE MOIETY01ZG3TPX31WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
glyceryl behenateINACTIVE INGREDIENTR8WTH25YS2WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
methacrylic acid - ethyl acrylate copolymer (1:1) type aINACTIVE INGREDIENTNX76LV5T8JWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
povidoneINACTIVE INGREDIENTFZ989GH94EWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-138WELLBUTRIN XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110622_fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
993545Wellbutrin XL 150 MG 24HR Extended Release Oral TabletPSNfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
993564Wellbutrin XL 300 MG 24HR Extended Release Oral TabletPSNfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
99354524 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet [Wellbutrin]SBDfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
99356424 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet [Wellbutrin]SBDfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
99354524 HR Wellbutrin 150 MG Extended Release Oral TabletSYfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
99356424 HR Wellbutrin 300 MG Extended Release Oral TabletSYfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
993545Wellbutrin XL 150 MG 24 HR Extended Release Oral TabletSYfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1
993564Wellbutrin XL 300 MG 24 HR Extended Release Oral TabletSYfdd1fa5e-9dbf-4951-a8e9-33d06e05bdba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-138-152169501381515 in 1 BOTTLEHistorical
21695-138-302169501383030 in 1 BOTTLEHistorical