Bupropion Hydrochloride

Product NDC
0904-7084
11-digit product format
009047084
Labeler code
0904
Product ID
0904-7084_817668bf-0adf-42e9-ad65-d2f28fcdd09b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA210015
Marketing category
ANDA
Marketing start
2018-12-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7084-04EA - Each0904-708423ae1280-3721-4d00-a641-d4d5f575589a12021-11-09
0904-7084-61EA - Each0904-70843d4e7f94-8fb0-408c-9e0d-75f651919bfd12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7084BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]5Legacy NDC20250316_1f9811c7-be3d-4f72-bea7-04a25a4b0635.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7084-040090470840430 BLISTER PACK in 1 CARTON (0904-7084-04) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2018-12-010000-00-00NoNoCurrent
0904-7084-6100904708461100 BLISTER PACK in 1 CARTON (0904-7084-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2018-12-010000-00-00NoNoCurrent