bupropion

Product NDC
68071-5214
11-digit product format
680715214
Labeler code
68071
Product ID
68071-5214_d7749ec8-c01c-7a8d-e053-2995a90a1b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202304
Marketing category
ANDA
Marketing start
2014-11-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5214-12022-02-07C16284748780-1d6a99b39-5395-a426-e053-dadaa90af4c2a11369c6-10a4-5ec4-e053-2995a90a241f
68071-5214-12022-01-28C16284748780-1d6a99b39-5395-a426-e053-dadaa90af4c2a11369c6-10a4-5ec4-e053-2995a90a241f

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5214-168071521401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-5214-1) 2020-03-170000-00-00NoNoCurrent