BUPROPION HYDROCHLORIDE

Product NDC
70518-2772
11-digit product format
705182772
Labeler code
70518
Product ID
70518-2772_ea377fc4-90aa-de89-e053-2a95a90a4dfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210497
Marketing category
ANDA
Marketing start
2020-06-08
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
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
70518-2772-2EA - Each70518-2772bf1bc540-73f4-4731-94d1-43b28af4d70312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2772BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]11Legacy NDC20250403_e187f83e-ee5e-46d9-9b4f-7e818d16776d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2772-07051827720090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2772-0) 2020-06-080000-00-00NoNoCurrent
70518-2772-17051827720130 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2772-1) 2020-11-050000-00-00NoNoCurrent
70518-2772-27051827720290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2772-2) 2021-02-260000-00-00NoNoCurrent
70518-2772-37051827720330 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2772-3) 2021-07-090000-00-00NoNoCurrent