WELLBUTRIN XL
WELLBUTRIN XL (bupropion hydrochloride extended-release tablets)
Approved
Approval ID
fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-137
Application NumberNDA021515
Product Classification
M
Marketing Category
C73594
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2010
FDA Product Classification
INGREDIENTS (9)
bupropion hydrochlorideActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIM
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
methacrylic acid - ethyl acrylate copolymer (1:1) type aInactive
Code: NX76LV5T8J
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-138
Application NumberNDA021515
Product Classification
M
Marketing Category
C73594
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2010
FDA Product Classification
INGREDIENTS (9)
bupropion hydrochlorideActive
Quantity: 300 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIM
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
methacrylic acid - ethyl acrylate copolymer (1:1) type aInactive
Code: NX76LV5T8J
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT